Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3873 

enrolled suppliers when they are 

reporting a change in their ownership, 

a change in their current Medicare 

enrollment information, or are 

revalidating or reactivating their 

Medicare enrollment. Form Number: 

CMS–855B (OMB control number: 

0938–1377); Frequency: Occasionally; 

Affected Public: Private Sector; Business 

or other for-profits, and Not-for Profits; 

Number of Respondents: 132,800; 

Number of Responses: 132,800; Total 

Annual Hours: 155,884. (For questions 

regarding this collection, contact Frank 

Whalen at 410–786–1302 or 

Frank.Whelan@cms.hhs.gov.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2025–00696 Filed 1–14–25; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0168] 

Growing, Harvesting, Processing, and 

Distribution of Poppy Seeds—Industry 

Practices Related to Opiate Alkaloids; 

Request for Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

requesting information on industry 

practices related to poppy seeds, such as 

information about growing, harvesting, 

processing, and distribution of poppy 

seeds, including industry practices to 

reduce the opiate alkaloid content of 

poppy seeds. We are taking this action, 

in part, because we have received 

reports of adverse events related to the 

use of some poppy seed products. We 

intend to use the information to help 

determine what type(s) of actions, if 

any, we should take to help ensure that 

poppy seed products do not pose a 

health risk when consumed. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by April 15, 2025. 

ADDRESSES: You may submit comments 

and information as follows. Please note 

that late, untimely filed comments will 

not be considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 15, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2021–P–0168 for ‘‘Growing, Harvesting, 

Processing, and Distribution of Poppy 

Seeds—Industry Practices related to 

Opiate Alkaloids; Request for 

Information.’’ Received comments, 

those filed in a timely manner (see 

ADDRESSES), will be placed in the docket 

and, except for those submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Jesse Lunzer, Office of Food Chemical 

Safety, Dietary Supplements, and 

Innovation, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2879, or Holli Kubicki, Office 

of Policy, Regulations, and Information, 

Human Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is requesting information on 

industry practices related to poppy 

seeds, such as information about 

growing, harvesting, processing, and 

distribution of poppy seeds, including 

industry practices to reduce the opiate 

alkaloid content of poppy seeds. The 

opium poppy (Papaver somniferum), or 

the ‘‘poppy plant,’’ is cultivated for food 

use, decorative use, ornamental use, and 


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3874 Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 

medicinal purposes. In the poppy plant, 

seeds grow inside an enclosed round 

fruit that is often referred to as a 

‘‘capsule’’ or ‘‘seed capsule.’’ The poppy 

plant produces substances, including 

alkaloids, to maintain the biological 

processes needed to grow and 

reproduce. Morphine, codeine, and 

thebaine are alkaloids produced by 

poppy plants and are referred to as 

opiate alkaloids. 

The scientific literature and FDA’s 

preliminary surveillance sampling show 

that poppy seeds may have varying 

amounts of opiate alkaloids and that 

opiate alkaloids may be present on 

poppy seeds or in poppy seedcontaining foods. Opiate alkaloid 

exposure may cause a range of side 

effects, including unusual dizziness or 

lightheadedness, sedation, extreme 

sleepiness, slowed or difficult breathing, 

unresponsiveness, respiratory arrest, 

and, in some cases, death. Reports of 

adverse events associated with poppy 

seed consumption have also garnered 

concern among citizens and consumer 

groups such as the Center for Science in 

the Public Interest (Ref. 1). 

FDA is aware that some consumers 

have used poppy seeds to produce a 

‘‘poppy seed tea’’ that has been linked 

to serious adverse events, including 

death. ‘‘Tea’’ is a misnomer, as the 

beverage is a solution that results from 

rinsing the opiate alkaloid-containing 

latex residue from the outer hull of the 

poppy seeds using cold water, and not 

an infusion created by steeping the 

seeds in hot water. To date, FDA has 

received nine reports of deaths 

purportedly associated with the 

consumption of homemade poppy seed 

tea. The cause of death for eight cases 

was morphine intoxication, often with 

codeine from poppy seeds and other 

substances (prescription opioids, 

benzodiazepines, anticonvulsants, 

mitragynine (kratom), and cannabis) 

also involved. 

FDA’s efforts to expand our 

understanding of opiate alkaloids on 

poppy seeds and consumer behaviors 

related to poppy seed consumption 

include surveillance sampling and 

testing poppy seeds from marketed 

products to determine their opiate 

alkaloid content. Twenty-one samples 

taken from poppy seeds purchased 

online showed morphine levels between 

1 milligram per kilogram (mg/kg) and 

520 mg/kg (median 70 mg/kg; mean 

120.4 mg/kg) and codeine levels 

between 0.8 mg/kg and 255 mg/kg 

(median 85 mg/kg; mean 113.1 mg/kg). 

We also have been examining 

agricultural and manufacturing 

practices related to poppy seeds and are 

interested in learning whether there are 

agricultural or manufacturing practices 

that might reduce the presence of the 

opiate alkaloids on poppy seeds. 

Our current understanding is that 

most opiate alkaloids on poppy seeds 

are deposited on the seeds by means of 

contact with liquid or dried latex that 

may occur through pod/capsule damage 

and/or particulate latex-derived dust 

through growing, harvesting, and 

processing practices (Refs. 2–4). Because 

these practices may vary depending on 

the grower or manufacturer and the 

intended use of the poppy plant (e.g., 

whether it is grown for food or 

pharmaceutical purposes), we would 

like more detailed information about the 

specific practices and processes from 

growth of the poppy plant and 

harvesting of poppy seeds to the 

processing and manufacturing of poppy 

seeds and poppy seed food products in 

the marketplace. 

Accordingly, we are seeking 

additional information on industry 

practices, such as information about the 

poppy seed supply chain and 

harvesting, handling, and testing 

practices, as well as manufacturing, 

processing, or other practices available 

and in use by industry to reduce or 

otherwise affect the opiate alkaloid 

content of poppy seeds. This 

information would help FDA 

understand existing industry practices 

and determine what type(s) of actions, 

if any, we should take to help to ensure 

that poppy seed products do not pose a 

health risk when consumed. 

II. Issues for Consideration and Request 

for Information 

We invite comment in response to the 

questions below. Please explain your 

answers and provide references and 

data, if possible. Including contextual 

information about your role(s) in the 

poppy seed industry (e.g., grower, 

importer, retailer) would also be 

helpful. 

A. Questions About Growing, 

Harvesting, and Post-Harvest Processes 

of Poppy Plant Crops and Poppy Seeds 

As background, a poppy plant’s 

production of opiate alkaloids varies 

based on certain environmental, 

biological, and inter-cultivar genetic 

variation. In addition, we are aware that 

agricultural practices that occur during 

poppy plant growth may impact 

opportunities for opiate alkaloidcontaining latex to be deposited on 

seeds (Refs. 2–5 and 9). 

Dried mature poppy plants are 

commonly harvested by using 

mechanized harvesting machinery that 

cuts and removes the above-ground 

plants after the plants have died and 

dried out in the field (Refs. 6–9). We 

want to learn about the types of 

harvesting practices and machinery 

used, because harvesting dried plants 

can result in the production of opiate 

alkaloid-containing dust or particulate 

plant tissue that may be deposited on 

the seeds (Ref. 9). 

We also are aware of some practices 

that are used to separate seeds from the 

seed capsules. For example, firms might 

use threshing machines, which crush 

the capsules and release the seeds. 

Other practices involve use of sieves, 

gravity tables, or other cleaning 

machines intended to separate the seeds 

from debris (such as small fragments of 

capsules, stems, or rocks) by shaking or 

blowing air through a permeable surface 

and separating plant material by size 

(Ref. 8). Opiate alkaloids might be 

transferred to the outer surface of poppy 

seeds during various harvesting and 

post-harvesting steps. 

Question 1: Please tell us about the 

growing, harvesting, and post-harvest 

processes used to produce poppy plant 

crops and seeds and what types of 

equipment are used for these processes. 

What, if any, are the different processes 

used for different geographic areas 

where the plant(s) are grown and why 

are the different processes used? We are 

particularly interested in information 

about good agricultural practices, 

scoring or nicking pods, harvesting 

procedures, cleaning and separation of 

plant parts, opiate alkaloid testing 

method and frequency, thermal 

treatments (e.g., to degrade opiate 

alkaloids), packaging, cleaning of 

equipment, frequency of cleaning, and 

storage. 

Question 2: Do buyers of poppy plants 

request specific varieties or cultivars 

based on the amount of opiate alkaloid 

produced by the variety or cultivar? If 

so, what are the specific varieties or 

cultivars and, if known, what are the 

preferred uses for these varieties or 

cultivars, and why are those varieties or 

cultivars preferred? 

Question 3: What types of equipment 

(e.g., agricultural threshers, combines, 

cultivators, other equipment) are used 

for harvesting poppy plants? FDA is 

aware that machine harvesting can 

result in opiate alkaloids being 

deposited on poppy seeds (Ref. 9). 

Please elaborate on style, model, 

settings, etc. 

Question 4: What practices are used to 

monitor, control, reduce, or otherwise 

affect poppy seed opiate alkaloid 

content, such as opiate alkaloid testing 

or poppy seed heat treatments (Refs. 10– 

12)? We are particularly interested in 

information on the types of practices to 

reduce opiate alkaloids and frequency of 


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Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3875 

use of the practices, as well as any 

evidence of their impact on the opiate 

alkaloid content of poppy seeds and the 

quality of the seeds. 

B. Questions About Poppy Seed Supply 

Chain 

We also seek information about 

distribution chains of poppy seeds and 

activities conducted during distribution 

(for example, opioid alkaloid testing and 

poppy seed heat treatment). Poppy 

seeds might be sourced from poppy 

plants that are grown solely for food 

use. In addition, seeds from poppy 

plants that are grown for pharmaceutical 

purposes might be sold for human food 

consumption (Refs. 4 and 6). Thus, FDA 

also wants to better understand the 

practices of companies that sell poppy 

capsules and seeds from plants grown 

for pharmaceutical purposes to entities 

involved in food manufacturing and 

distribution, at all points in time from 

the growth of poppy plants to the sale 

of poppy seeds. Cultivars grown for 

pharmaceutical purposes may produce 

higher opiate alkaloids compared to 

cultivars grown solely for food use, 

which may result in higher opiate 

alkaloid content on seeds. These 

cultivars and their seeds might be more 

affected by the practices involved in 

growing, harvesting, processing, and 

distribution. 

Question 5: What are the various 

intermediaries and processes that are 

part of the supply chain for poppy 

seeds? Please include information about 

what intermediaries (such as brokers, 

exporters, importers, consolidators, 

manufacturers, and retailers) and 

processes (such as opiate alkaloid 

testing, testing frequency, packing, sale, 

and transportation) might be involved at 

various stages throughout the poppy 

seed supply chain. 

Question 6: What activities are 

performed in the distribution chains of 

poppy seeds? For example, do 

distributors or wholesalers engage in 

opioid alkaloid testing and heat 

treatments of poppy seeds? If so, what 

types of testing, treatments, or other 

activities are performed and how 

frequently are such activities 

performed? 

Question 7: Describe the role of any 

brokers or other intermediary 

distributors that sell poppy seeds 

between pharmaceutical companies (or 

poppy plants grown for pharmaceutical 

use) and food manufacturers. Do brokers 

or other intermediary distributors 

request poppy seeds from specific 

cultivars of poppy plants? If so, what are 

these specific cultivars? 

Question 8: Do brokers or other 

intermediary distributors typically sell 

poppy seeds direct to retailers or 

individual consumers? What additional 

precautions or steps are taken when 

selling directly to retailers or 

consumers? 

C. Questions About Processing and 

Manufacturing From Poppy Plants to 

Poppy Seeds 

We want additional information about 

other post-harvest practices conducted 

by manufacturers to control or reduce, 

or that may otherwise affect, poppy seed 

opiate alkaloid content, such as if opiate 

alkaloid testing (at any point) or poppy 

seed heat treatments are performed 

(Refs. 10–12). More information on the 

types of practices to reduce opiate 

alkaloids and frequency of the practices, 

as well as any evidence on their impact 

on the opiate alkaloid content of poppy 

seeds and the quality of the seeds, 

would be useful. 

Question 9: What manufacturing 

processes are used to manufacture 

poppy seed food products and what 

processes are applied to reduce poppy 

seeds’ opiate alkaloid content? 

Information about any processes, such 

as initial inspection, cleaning or 

separation of plant parts, mixing, 

crushing, blending, treatments such as 

heating or washing, drying, cleaning of 

equipment, cleaning frequency, 

packaging, testing, testing type, and 

transportation, used to process poppy 

seeds and manufacture poppy seed 

products would be useful. 

Question 10: When using contract 

growers or otherwise procuring seeds, 

what specific varieties, cultivars, 

characteristics (e.g., color, aroma, opiate 

alkaloid levels), or other specifications 

are typically required for food use? 

Question 11: If you are a manufacturer 

of poppy seeds or poppy seed products, 

what types of customers (e.g., 

manufacturers of other products, 

retailers, individual customers) do you 

sell to? What additional precautions or 

steps, if any, are taken when selling to 

various customers? 

Question 12: If you are a manufacturer 

of poppy seeds or poppy seed products, 

what types of sellers (e.g., 

manufacturers of other products, 

growers, other sources) do you buy 

poppy seeds from? What additional 

precautions or steps, if any, are taken 

when buying from various sellers? 

III. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. FDA 

has verified the website addresses, as of 

the date this document publishes in the 

Federal Register, but websites are 

subject to change over time. 

*1. Center for Science in the Public Interest 

Citizen Petition, February 5, 2021, 

Docket No. FDA–2021–P–0168). 

*2. BfR (Bundesinstitut fu ̈r 

Risikobewertung—Federal Institute for 

Risk Assessment), 2005. ‘‘BfR 

Recommends Provisional Daily Upper 

Intake Level and a Guidance Value for 

Morphine in Poppy Seeds.’’ BfR Health 

Assessment No. 012/2006, 27 December 

2005. Available at http://

www.bfr.bund.de/cm/245/bfr_

recommends_provisional_daily_upper_

intake_level_and_a_guidance_value_for_

morphine_in_poppy_seeds.pdf (accessed 

September 13, 2024). 

*3. European Food Safety Authority (EFSA) 

Panel on Contaminants in the Food 

Chain (CONTAM). ‘‘Scientific Opinion 

on the Risks for Public Health Related to 

the Presence of Opium Alkaloids in 

Poppy Seeds.’’ EFSA Journal, 9(11):2405, 

2011. Available at https://doi.org/ 

10.2903/j.efsa.2011.2405 (accessed 

September 13, 2024). 

*4. EFSA Panel on Contaminants in the Food 

Chain (CONTAM), et al. ‘‘Update of the 

Scientific Opinion on Opium Alkaloids 

in Poppy Seeds.’’ EFSA Journal, 

16(5):e05243, 2018. Available at https:// 

doi.org/10.2903/j.efsa.2018.5243 

(accessed September 13, 2024). 

*5. European Union ‘‘Commission 

Recommendation of 10 September 2014 

on Good Practices to Prevent and to 

Reduce the Presence of Opium Alkaloids 

in Poppy Seeds and Poppy Seed 

Products.’’ 2014/662/EU. Official Journal 

of the European Union, L271/96. 

Available at https://eur-lex.europa.eu/ 

legal-content/EN/TXT/ 

?uri=uriserv%3AOJ.L_

.2014.271.01.0096.01.

ENG&toc=OJ%3AL%3A2014%

3A271%3ATOC (accessed September 13, 

2024). 

*6. Fist, A.J. ‘‘The Tasmanian Poppy 

Industry: A Case Study of the 

Application of Science and Technology.’’ 

Proceedings of the Australian Agronomy 

Conference. 2001. Available at https://

nla.gov.au/nla.obj-1382338968/view 

(accessed September 13, 2024). 

7. Martinov, M. and M. Konstantinovic. 

‘‘Chapter 2: Harvesting,’’ in Medicinal 

and Aromatic Crops: Harvesting, Drying, 

and Processing. O ̈ ztekin, S., Martino, M., 

The Hawthorn Press, Inc. 2007. 

8. Feje ́r, J. and I. Salamon. ‘‘Agro-Technology 

of the Poppy: Large-Scale Cultivation in 

Slovakia.’’ International Symposium on 


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Papaver 1036. 2014. 

9. Montgomery, M.T., X.A. Conlan, A.G. 

Theakstone, et al. ‘‘Extraction and 

Determination of Morphine Present on 

the Surface of Australian Food Grade 

Poppy Seeds Using Acidic Potassium 

Permanganate Chemiluminescence 

Detection.’’ Food Analytical Methods, 

13(5):1159–1165, 2020. Available at 

https://doi.org/10.1007/s12161-020-

01729-z (accessed December 8, 2024). 

10. Lo, D. and T. Chua. ‘‘Poppy Seeds: 

Implications of Consumption.’’ 

Medicine, Science and the Law, 

32(4):296–302, 1992. Available at https:// 

doi.org/10.1177/002580249203200403 

(accessed December 8, 2024). 

11. Sproll, C., R.C. Perz, R. Buschmann, et al. 

‘‘Guidelines for Reduction of Morphine 

in Poppy Seed Intended for Food 

Purposes.’’ European Food Research and 

Technology, 226(1):307–310, 2007. 

Available at https://doi.org/10.1007/

s00217-006-0522-7 (accessed December. 

8, 2024). 

12. Shetge, S.A., M.P. Dzakovich, J.L. 

Cooperstone, et al. ‘‘Concentrations of 

the Opium Alkaloids Morphine, 

Codeine, and Thebaine in Poppy Seeds 

are Reduced After Thermal and Washing 

Treatments But Are Not Affected When 

Incorporated in a Model Baked Product.’’ 

Journal of Agricultural and Food 

Chemistry, 68(18):5241–5248, 2020. 

Available at https://doi.org/10.1021/ 

acs.jafc.0c01681 (accessed December 8, 

2024). 

Dated: January 8, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00757 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5964] 

Teva Pharmaceuticals USA, Inc., et al.; 

Withdrawal of Approval of 23 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 23 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

February 14, 2025. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in table 1 have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1—ANDAS FOR WHICH APPROVAL IS WITHDRAWN

Application No. Drug Applicant 

ANDA 040454 .... Promethazine Hydrochloride (HCl) injectable, 25 milligrams 

(mg)/milliliters (mL) and 50 mg/mL.

Teva Pharmaceuticals USA, Inc., 400 Interpace Parkway, 

Bldg. A, Parsippany, NJ 07054. 

ANDA 040593 .... Promethazine HCl injectable, 25 mg/mL and 50 mg/mL ......... Sandoz Inc., 100 College Rd. West, Princeton, NJ 08540. 

ANDA 064042 .... Nystatin suspension, 100,000 units/mL ................................... PAI Holdings, LLC, dba Pharmaceutical Associates, Inc., and 

dba PAI Pharma, 1700 Perimeter Rd., Greenville, SC 

29605. 

ANDA 074811 .... Haloperidol Decanoate injectable, Equivalent to (EQ) 50 mg 

base/mL.

Hikma Pharmaceuticals USA Inc., 2 Esterbrook Lane, Cherry 

Hill, NJ 08003. 

ANDA 076061 .... Pergolide Mesylate tablet, EQ 0.05 mg base, EQ 0.25 mg 

base, and EQ 1 mg base.

Strides Pharma Inc., U.S. Agent for Strides Pharma Global 

Pte Ltd., 2 Tower Center Blvd., Suite 1102, East Brunswick, NJ 08816. 

ANDA 079075 .... Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, 

EQ 0.4 mg base, EQ 0.6 mg base, and EQ 0.8 mg base.

Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Parkway, Bldg. A, Parsippany, NJ 07054. 

ANDA 079240 .... Sumatriptan Succinate injectable, EQ 6 mg base/0.5 mL (EQ 

12 mg base/mL) and EQ 4 mg base/0.5 mL (EQ 8 mg 

base/mL).

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 

ANDA 084591 .... Promethazine HCl injectable, 25 mg/mL ................................. Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.). 

ANDA 090016 .... Irinotecan HCl injectable, 40 mg/2mL (20 mg/mL) and 100 

mg/5 mL (20 mg/mL).

Hisun Pharmaceuticals USA Inc., U.S. Agent for Hisun Pharmaceutical (Hangzhou) Co., Ltd., 200 Crossing Blvd., 2nd 

Floor, Bridgewater, NJ 08807. 

ANDA 200536 .... Ranitidine HCl tablet, EQ 150 mg base .................................. Strides Pharma Inc., U.S. Agent for Strides Pharma Global 

Pte Ltd. 

ANDA 201745 .... Ranitidine HCl tablet, EQ 75 mg base .................................... Do. 

ANDA 204991 .... Atorvastatin Calcium tablet, EQ 10 mg base, EQ 20 mg 

base, EQ 40 mg base, and EQ 80 mg base.

Lupin Pharmaceuticals, Inc., U.S. Agent for Lupin Ltd., 

Harborplace Tower, 111 South Calvert St., 21st Floor, Baltimore, MD 21202. 

ANDA 205512 .... Ranitidine HCl tablet, EQ 150 mg base and EQ 300 mg base Strides Pharma Inc., U.S. Agent for Strides Pharma Global 

Pte Ltd. 

ANDA 206155 .... Olanzapine tablet, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 

20 mg.

RegCon Solutions, LLC, U.S. Agent for Indoco Remedies 

Ltd., 9920 Pacific Heights Blvd., Suite 250, San Diego, CA 

92121. 

ANDA 206204 .... Piperacillin and Tazobactam injectable, EQ 12 grams (g) 

base/vial; EQ 1.5 g base/vial.

Fresenius Kabi USA, LLC. 

ANDA 207338 .... Fentanyl Citrate tablet, EQ 0.1 mg base, EQ 0.2 mg base, 

EQ 0.3 mg base, EQ 0.4 mg base, EQ 0.6 mg base, and 

EQ 0.8 mg base.

Actavis Laboratories FL, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA Inc.), 400 Interpace 

Parkway, Bldg. A, Parsippany, NJ 07054. 


lotter on DSK11XQN23PROD with NOTICES1