40588 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

removed the SBIAB indication from its 

labeling, consistent with this decision. 

In addition, FDA will continue to accept 

and, where appropriate, approve 

ANDAs that refer to CECLOR CD 

(cefaclor extended-release tablets) as 

long as they meet relevant legal and 

regulatory requirements, but FDA will 

not accept or approve ANDAs that refer 

to this drug product and propose to 

include the SBIAB indication. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16050 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0698] 

Outsourcing Facility Fee Rates for 

Fiscal Year 2022 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

fiscal year (FY) 2022 rates for the 

establishment and reinspection fees 

related to entities that compound 

human drugs and elect to register as 

outsourcing facilities under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act). The FD&C Act authorizes FDA to 

assess and collect an annual 

establishment fee from outsourcing 

facilities, as well as a reinspection fee 

for each reinspection of an outsourcing 

facility. This document establishes the 

FY 2022 rates for the small business 

establishment fee ($5,824), the nonsmall business establishment fee 

($18,999), and the reinspection fee 

($17,472) for outsourcing facilities; 

provides information on how the fees 

for FY 2022 were determined; and 

describes the payment procedures 

outsourcing facilities should follow. 

These fee rates are effective October 1, 

2021, and will remain in effect through 

September 30, 2022. 

FOR FURTHER INFORMATION CONTACT: For 

more information on human drug 

compounding and outsourcing facility 

fees: Visit FDAs website at: https://

www.fda.gov/Drugs/ 

GuidanceCompliance

RegulatoryInformation/ 

PharmacyCompounding/default.htm. 

For questions relating to this notice: 

Melissa Hurley, Office of Financial 

Management, Food and Drug 

Administration, 4041 Powder Mill Rd., 

Rm. 61075, Beltsville, MD 20705–4304, 

240–402–4585. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Under section 503B of the FD&C Act 

(21 U.S.C. 353b), a human drug 

compounder can become an 

‘‘outsourcing facility.’’ Outsourcing 

facilities, as defined in section 

503B(d)(4), are facilities that meet all 

the conditions described in section 

503B(a), including registering with FDA 

as an outsourcing facility and paying an 

annual establishment fee. If the 

conditions of section 503B are met, a 

drug compounded by or under the 

direct supervision of a licensed 

pharmacist in an outsourcing facility is 

exempt from three sections of the FD&C 

Act: (1) Section 502(f)(1) (21 U.S.C. 

352(f)(1)) concerning the labeling of 

drugs with adequate directions for use; 

(2) section 505 (21 U.S.C. 355) 

concerning the approval of human drug 

products under new drug applications 

(NDAs) or abbreviated new drug 

applications (ANDAs); and (3) section 

582 (21 U.S.C. 360eee–1) concerning 

drug supply chain security 

requirements. Drugs compounded in 

outsourcing facilities are not exempt 

from the requirements of section 

501(a)(2)(B) of the FD&C Act (21 U.S.C. 

351(a)(2)(B)) concerning current good 

manufacturing practice requirements for 

drugs. 

Section 744K of the FD&C Act (21 

U.S.C. 379j–62) authorizes FDA to 

assess and collect the following fees 

associated with outsourcing facilities: 

(1) An annual establishment fee from 

each outsourcing facility and (2) a 

reinspection fee from each outsourcing 

facility subject to a reinspection (see 

section 744K(a)(1) of the FD&C Act). 

Under statutorily defined conditions, a 

qualified applicant may pay a reduced 

small business establishment fee (see 

section 744K(c)(4) of the FD&C Act). 

FDA announced in the Federal 

Register of November 24, 2014 (79 FR 

69856), the availability of a final 

guidance for industry entitled ‘‘Fees for 

Human Drug Compounding Outsourcing 

Facilities Under Sections 503B and 

744K of the FD&C Act.’’ The guidance 

provides additional information on the 

annual fees for outsourcing facilities 

and adjustments required by law, 

reinspection fees, how to submit 

payment, the effect of failure to pay fees, 

and how to qualify as a small business 

to obtain a reduction of the annual 

establishment fee. This guidance can be 

accessed on FDA’s website at: https://

www.fda.gov/media/136683/download. 

II. Fees for FY 2022 

A. Methodology for Calculating FY 2022 

Adjustment Factors 

1. Inflation Adjustment Factor 

Section 744K(c)(2) of the FD&C Act 

specifies the annual inflation 

adjustment for outsourcing facility fees. 

The inflation adjustment has two 

components: One based on FDA’s 

payroll costs and one based on FDA’s 

non-payroll costs for the first 3 of the 4 

previous fiscal years. The payroll 

component of the annual inflation 

adjustment is calculated by taking the 

average change in FDA’s per-full time 

equivalent (FTE) personnel 

compensation and benefits (PC&B) in 

the first 3 of the 4 previous fiscal years 

(see section 744K(c)(2)(A)(ii) of the 

FD&C Act). FDA’s total annual spending 

on PC&B is divided by the total number 

of FTEs per fiscal year to determine the 

average PC&B per FTE. 

Table 1 summarizes the actual cost 

and FTE data for the specified fiscal 

years, and provides the percent change 

from the previous fiscal year and the 

average percent change over the first 3 

of the 4 fiscal years preceding FY 2022. 

The 3-year average is 2.7383 percent. 

TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE

Fiscal year 2018 2019 2020 3-Year 

average 

Total PC&B .......................................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ........................

Total FTE ............................................................................................. 17,023 17,144 17,535 ........................

PC&B per FTE ..................................................................................... $158,061 $152,826 $163,992 ........................

Percent change from previous year .................................................... 4.2206 ¥3.3120 7.3063 2.7383 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40589 

Section 744K(c)(2)(A)(ii) of the FD&C 

Act specifies that this 2.7383 percent 

should be multiplied by the proportion 

of PC&B to total costs of an average FDA 

FTE for the same 3 fiscal years. 

TABLE 2—FDA PC&BS AS A PERCENT OF FDA TOTAL COSTS OF AN AVERAGE FTE 

Fiscal year 2018 2019 2020 3-Year 

average 

Total PC&B .......................................................................................... $2,690,678,000 $2,620,052,000 $2,875,592,000 ........................

Total Costs ........................................................................................... $5,370,935,000 $5,663,389,000 $6,039,321,000 ........................

PC&B Percent ...................................................................................... 50.0970 46.2630 47.6145 47.9915 

The payroll adjustment is 2.7383 

percent multiplied by 47.9915 percent, 

or 1.3142 percent. 

Section 744K(c)(2)(A)(iii) of the FD&C 

Act specifies that the portion of the 

inflation adjustment for non-payroll 

costs for FY 2022 is equal to the average 

annual percent change in the Consumer 

Price Index (CPI) for urban consumers 

(U.S. City Average; Not Seasonally 

Adjusted; All items; Annual Index) for 

the first 3 years of the preceding 4 years 

of available data, multiplied by the 

proportion of all non-PC&B costs to total 

costs of an average FDA FTE for the 

same period. 

Table 2 provides the summary data 

for the percent change in the specified 

CPI for U.S. cities. These data are 

published by the Bureau of Labor 

Statistics and can be found on its 

website: https://data.bls.gov/cgi-bin/ 

surveymost?cu. The data can be viewed 

by checking the box marked ‘‘U.S. city 

average, All items—CUUR0000SA0’’ 

and then selecting ‘‘Retrieve Data.’’ 

TABLE 3—ANNUAL AND 3-YEAR AVERAGE PERCENT CHANGE IN U.S. CITY AVERAGE CPI 

Year 2018 2019 2020 3-Year 

average 

Annual CPI ....................................................................................................... 251.107 255.657 258.811 ........................

Annual Percent Change .................................................................................. 2.4425 1.8120 1.2337 1.8294 

Section 744K(c)(2)(A)(iii) of the FD&C 

Act specifies that this 1.8294 percent 

should be multiplied by the proportion 

of all non-PC&B costs to total costs of an 

average FTE for the same 3 fiscal years. 

The proportion of all non-PC&B costs to 

total costs of an average FDA FTE for 

FYs 2018 to 2020 is 52.0085 percent 

(100 percent minus 47.9915 percent 

equal 52.0085 percent). Therefore, the 

non-pay adjustment is 1.8294 percent 

times 52.0085 percent, or 0.9514 

percent. 

The PC&B component (1.3142 

percent) is added to the non-PC&B 

component (0.9514 percent), for a total 

inflation adjustment of 2.2656 percent 

(rounded). Section 744K(c)(2)(A)(i) of 

the FD&C Act specifies that one is 

added to that figure, making the 

inflation adjustment 1.022656. 

Section 744K(c)(2)(B) of the FD&C Act 

provides for this inflation adjustment to 

be compounded after FY 2015. This 

factor for FY 2022 (2.2656 percent) is 

compounded by adding one to it, and 

then multiplying it by one plus the 

inflation adjustment factor for FY 2021 

(13.8991 percent), as published in the 

Federal Register on August 4, 2020 (85 

FR 47225). The result of this 

multiplication of the inflation factors for 

the 7 years since FY 2015 (1.022656 × 

1.138991) becomes the inflation 

adjustment for FY 2022. For FY 2022, 

the inflation adjustment is 16.4796 

percent (rounded). We then add one, 

making the FY 2022 inflation 

adjustment factor 1.164796. 

2. Small Business Adjustment Factor 

Section 744K(c)(3) of the FD&C Act 

specifies that in addition to the inflation 

adjustment factor, the establishment fee 

for non-small businesses is to be further 

adjusted for a small business adjustment 

factor. Section 744K(c)(3)(B) of the 

FD&C Act provides that the small 

business adjustment factor is the 

adjustment to the establishment fee for 

non-small businesses that is necessary 

to achieve total fees equaling the 

amount that FDA would have collected 

if no entity qualified for the small 

business exception in section 744K(c)(4) 

of the FD&C Act. Additionally, section 

744K(c)(5)(A) states that in establishing 

the small business adjustment factor for 

a fiscal year, FDA shall provide for the 

crediting of fees from the previous year 

to the next year if FDA overestimated 

the amount of the small business 

adjustment factor for such previous 

fiscal year. 

Therefore, to calculate the small 

business adjustment to the 

establishment fee for non-small 

businesses for FY 2022, FDA must 

estimate: (1) The number of outsourcing 

facilities that will pay the reduced fee 

for small businesses for FY 2022 and (2) 

the total fee revenue it would have 

collected if no entity had qualified for 

the small business exception (i.e., if 

each entity that registers as an 

outsourcing facility for FY 2022 were to 

pay the inflation-adjusted fee amount of 

$17,472). 

With respect to (1), FDA estimates 

that 12 entities will qualify for small 

business exceptions and will pay the 

reduced fee for FY 2022. With respect 

to (2), to estimate the total number of 

entities that will register as outsourcing 

facilities for FY 2022, FDA used data 

submitted by outsourcing facilities 

through the voluntary registration 

process, which began in December 2013. 

Accordingly, FDA estimates that 80 

outsourcing facilities, including 12 

small businesses, will be registered with 

FDA in FY 2022. 

If the projected 80 outsourcing 

facilities paid the full inflation-adjusted 

fee of $17,472, this would result in total 

revenue of $1,397,760 in FY 2022 

($17,472 × 80). However, 12 of the 

entities that are expected to register as 

outsourcing facilities for FY 2022 are 

projected to qualify for the small 

business exception and to pay one-third 

of the full fee ($5,824 × 12), totaling 

$69,888 instead of paying the full fee 

($17,472 × 12), which would total 

$209,664. This would leave a potential 

shortfall of $139,776 ($209,664 minus 

$69,888). 

Additionally, section 744K(c)(5)(A) of 

the FD&C Act states that in establishing 

the small business adjustment factor for 

a fiscal year, FDA shall provide for the 


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1To qualify for a small business reduction of the 

FY 2022 establishment fee, entities had to submit 

their exception requests by April 30, 2021. See 

section 744K(c)(4)(B) of the FD&C Act. The time for 

requesting a small business exception for FY 2022 

has now passed. An entity that wishes to request 

a small business exception for FY 2023 should 

consult section 744K(c)(4) of the FD&C Act and 

section III.D of FDA’s guidance for industry entitled 

‘‘Fees for Human Drug Compounding Outsourcing 

Facilities Under Sections 503B and 744K of the 

FD&C Act,’’ which can be accessed on FDA’s 

website at https://www.fda.gov/media/136683/ 

download. 

crediting of fees from the previous year 

to the next year if FDA overestimated 

the amount of the small business 

adjustment factor for such previous 

fiscal year. FDA has determined that it 

is appropriate to credit excess fees 

collected from the last completed fiscal 

year, due to the inability to conclusively 

determine the amount of excess fees 

from the fiscal year that is in progress 

at the time this calculation is made. 

This crediting is done by comparing the 

small business adjustment factor for the 

last completed fiscal year, FY 2020 

($2,208), to what would have been the 

small business adjustment factor for FY 

2020 ($1,671) if FDA had estimated 

perfectly. 

The calculation for what the small 

business adjustment would have been if 

FDA had estimated perfectly begins by 

determining the total target collections 

(15,000 × [inflation adjustment factor] × 

[number of registrants]). For the most 

recent complete fiscal year, FY 2020, 

this was $1,293,446 ($16,798 × 77). The 

actual FY 2020 revenue from the 77 

total registrants (i.e., 67 registrants 

paying FY 2020 non-small business 

establishment fee and 10 small business 

registrants) paying establishment fees is 

$1,181,456. $1,181,456 is calculated as 

follows: (FY 2020 Non-Small Business 

Establishment Fee adjusted for inflation 

only) × (total number of registrants in 

FY 2020 paying Non-Small Business 

Establishment Fee) + (FY 2020 Small 

Business Establishment Fee) × (total 

number of small business registrants in 

FY 2020 paying Small Business 

Establishment Fee). $16,798 × 67 + 

$5,599 × 10 = $1,181,456. This left a 

shortfall of $111,990 from the estimated 

total target collection amount 

($1,293,446 minus $1,181,456). This 

amount ($111,990) divided by the total 

number of registrants in FY 2020 paying 

Standard Establishment Fee (67) equals 

$1,671. 

The difference between the small 

business adjustment factor used in FY 

2020 and the small business adjustment 

factor that would have been used had 

FDA estimated perfectly is $537 ($2,208 

minus $1,671). The $537 (rounded to 

the nearest dollar) is then multiplied by 

the number of actual registrants who 

paid the standard fee for FY 2020 (67), 

which provides us a total excess 

collection of $35,963 in FY 2020. 

Therefore, to calculate the small 

business adjustment factor for FY 2022, 

FDA subtracts $35,963 from the 

projected shortfall of $139,776 for FY 

2022 to arrive at the numerator for the 

small business adjustment amount, 

which equals $103,813. This number 

divided by 68 (the number of expected 

non-small businesses for FY 2022) is the 

small business adjustment amount for 

FY 2022, which is $1,527 (rounded to 

the nearest dollar). 

B. FY 2022 Rates for Small Business 

Establishment Fee, Non-Small Business 

Establishment Fee, and Reinspection 

Fee 

1. Establishment Fee for Qualified Small 

Businesses 1

The amount of the establishment fee 

for a qualified small business is equal to 

$15,000 multiplied by the inflation 

adjustment factor for that fiscal year, 

divided by 3 (see section 744K(c)(4)(A) 

and (c)(1)(A) of the FD&C Act). The 

inflation adjustment factor for FY 2022 

is 1.164796. See section II.A.1 for the 

methodology used to calculate the FY 

2022 inflation adjustment factor. 

Therefore, the establishment fee for a 

qualified small business for FY 2022 is 

one third of $17,472, which equals 

$5,824 (rounded to the nearest dollar). 

2. Establishment Fee for Non-Small 

Businesses 

Under section 744K(c) of the FD&C 

Act, the amount of the establishment fee 

for a non-small business is equal to 

$15,000 multiplied by the inflation 

adjustment factor for that fiscal year, 

plus the small business adjustment 

factor for that fiscal year, and plus or 

minus an adjustment factor to account 

for over or under collections due to the 

small business adjustment factor in the 

prior year. The inflation adjustment 

factor for FY 2022 is 1.164796. The 

small business adjustment amount for 

FY 2022 is $1,527. See section II.A.2 for 

the methodology used to calculate the 

small business adjustment factor for FY 

2022. Therefore, the establishment fee 

for a non-small business for FY 2022 is 

$15,000 multiplied by 1.164796 plus 

$1,527, which equals $18,999 (rounded 

to the nearest dollar). 

3. Reinspection Fee 

Section 744K(c)(1)(B) of the FD&C Act 

provides that the amount of the FY 2022 

reinspection fee is equal to $15,000, 

multiplied by the inflation adjustment 

factor for that fiscal year. The inflation 

adjustment factor for FY 2022 is 

1.164796. Therefore, the reinspection 

fee for FY 2022 is $15,000 multiplied by 

1.164796, which equals $17,472 

(rounded to the nearest dollar). There is 

no reduction in this fee for small 

businesses. 

C. Summary of FY 2022 Fee Rates 

TABLE 4—OUTSOURCING FACILITY

FEES

Qualified Small Business Establishment Fee ................ $5,824 

Non-Small Business Establishment Fee ..................... 18,999 

Reinspection Fee .................. 17,472 

III. Fee Payment Options and 

Procedures 

A. Establishment Fee 

Once an entity submits registration 

information and FDA has determined 

that the information is complete, the 

entity will incur the annual 

establishment fee. FDA will send an 

invoice to the entity, via email to the 

email address indicated in the 

registration file, or via regular mail if 

email is not an option. The invoice will 

contain information regarding the 

obligation incurred, the amount owed, 

and payment procedures. A facility will 

not be registered as an outsourcing 

facility until it has paid the annual 

establishment fee under section 744K of 

the FD&C Act. Accordingly, it is 

important that facilities seeking to 

operate as outsourcing facilities pay all 

fees immediately upon receiving an 

invoice. If an entity does not pay the full 

invoiced amount within 15 calendar 

days after FDA issues the invoice, FDA 

will consider the submission of 

registration information to have been 

withdrawn and adjust the invoice to 

reflect that no fee is due. 

Outsourcing facilities that registered 

in FY 2021 and wish to maintain their 

status as an outsourcing facility in FY 

2022 must register during the annual 

registration period that lasts from 

October 1, 2021, to December 31, 2021. 

Failure to register and complete 

payment by December 31, 2021, will 

result in a loss of status as an 

outsourcing facility on January 1, 2022. 

Entities should submit their registration 

information no later than December 10, 

2021, to allow enough time for review 

of the registration information, 

invoicing, and payment of fees before 

the end of the registration period. 

B. Reinspection Fee 

FDA will issue invoices for each 

reinspection after the conclusion of the 

reinspection, via email to the email 

address indicated in the registration file 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40591 

or via regular mail if email is not an 

option. Invoices must be paid within 30 

days. 

C. Fee Payment Procedures 

1. The preferred payment method is 

online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). Secure electronic payments 

can be submitted using the User Fees 

Payment Portal at—https://

userfees.fda.gov/pay. (Note: only full 

payments are accepted. No partial 

payments can be made online.) Once 

you search for your invoice, click ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances less than 

$25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

2. If paying with a paper check: 

Checks must be in U.S. currency from 

a U.S. bank and made payable to the 

Food and Drug Administration. 

Payments can be mailed to: Food and 

Drug Administration, P.O. Box 979033, 

St. Louis, MO 63197–9000. Include 

invoice number on check. If a check is 

sent by a courier that requests a street 

address, the courier can deliver the 

check to: U.S. Bank, Attn: Government 

Lockbox 979033, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. If you have any questions 

concerning courier delivery, contact the 

U.S. Bank at 314–418–4013). 

3. When paying by wire transfer, the 

invoice number must be included. 

Without the invoice number the 

payment may not be applied. Regarding 

reinspection fees, if the payment 

amount is not applied, the invoice 

amount will be referred to collections. 

The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee, it is required that the 

outsourcing facility add that amount to 

the payment to ensure that the invoice 

is paid in full. Use the following 

account information when sending a 

wire transfer: U.S. Dept of the Treasury, 

TREAS NYC, 33 Liberty St., New York, 

NY 10045, Acct. No. 75060099, Routing 

No. 021030004, SWIFT: FRNYUS33. If 

needed, FDA’s tax identification 

number is 53–0196965. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16057 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0652] 

Fresenius Kabi USA, LLC, et al.; 

Withdrawal of Approval of 15 

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 15 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 

August 27, 2021. 

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, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described 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. 

Application No. Drug Applicant 

ANDA 040265 ...................... Methotrexate Sodium Injection, Equivalent to (EQ) 25 

milligrams (mg) base/milliliters (mL).

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

Zurich, IL 60047. 

ANDA 070963 ...................... Clonidine Hydrochloride (HCl) Tablets, 0.3 mg .............. Watson Laboratories, Inc. (an indirect, wholly owned 

subsidiary of Teva Pharmaceuticals USA, Inc.), 400 

Interpace Pkwy., Bldg. A, Parsippany, NJ 07054. 

ANDA 074292 ...................... Dobutamine HCl Injection, EQ 12.5 mg base/mL .......... Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. 

ANDA 075069 ...................... Etodolac Tablets, 400 mg ............................................... Watson Laboratories, Inc. 

ANDA 075856 ...................... Midazolam HCl Injection, EQ 1 mg base/mL and EQ 5 

mg base/mL.

Hospira, Inc. 

ANDA 084504 ...................... Hydralazine HCl Tablets, 25 mg ..................................... Watson Laboratories, Inc. 

ANDA 090379 ...................... Budesonide Delayed Release Capsules, 3 mg .............. Barr Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 

Interpace Pkwy., Bldg. A, Morris Corporate Center III, 

Parsippany, NJ 07054. 

ANDA 091590 ...................... Losartan Potassium Tablets, 25 mg, 50 mg, and 100 

mg.

Mylan Pharmaceuticals Inc., a Viatris Company, 81 

Chestnut Ridge Rd., P.O. Box 4310, Morgantown, 

WV 26504. 

ANDA 091652 ...................... Hydrochlorothiazide and Losartan Potassium Tablets, 

12.5 mg/50 mg, 12.5 mg/100 mg, and 25 mg/100 mg.

Do. 

ANDA 204361 ...................... Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL ........ USV Private Limited, U.S. Agent, Omega Pharmaceutical Consulting, Inc., 752 West Shuhthagi Lane, 

New Harmony, UT 84757. 

ANDA 204362 ...................... Eptifibatide Injection, 2 mg/mL ........................................ Do. 


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