Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2017-N-5715]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 54 abbreviated new drug applications (ANDAs) from two applicants. The holders of the applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of November 24, 2017.
 FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945.


SUPPLEMENTARY INFORMATION: The holders of the applications 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 abbreviated application under § 314.150(c) is without prejudice to refiling. Table 1
Application No.
Drug
ApplicantANDA 061717
Doxycycline Hyclate Capsules USP, Equivalent to (EQ) 50 milligrams (mg) base and EQ 100 mg base
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 062087
Erythromycin Estolate Capsules USP, EQ 250 mg base
Do.ANDA 062318
Gentamicin Injection USP, EQ 10 mg base/milliliter (mL) and EQ 40 mg base/mL
Do.ANDA 062816
Ampicillin for Injection USP, EQ 125 mg base/vial, EQ 250 mg base/vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial
Do.ANDA 062994
Ampicillin for Injection USP, EQ 10 g base/vial
Do.ANDA 062999
Erythromycin Delayed-Release Tablets USP, 500 mg
Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.ANDA 064036
Cefuroxime for Injection USP, EQ 7.5 g base/vial
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.ANDA 070296
Diazepam Injection USP, 5 mg/mL
Do.ANDA 070412
Furosemide Tablets USP, 20 mg
Do.ANDA 070435
Ibuprofen Tablets USP, 200 mg
Do.ANDA 070436
Ibuprofen Tablets USP, 400 mg
Do.ANDA 070437
Ibuprofen Tablets USP, 600 mg
Do.ANDA 070449
Furosemide Tablets USP, 20 mg
Do.ANDA 070450
Furosemide Tablets USP, 40 mg
Do.ANDA 070515
Tolazamide Tablets USP, 500 mg
Do.ANDA 070528
Furosemide Tablets USP, 80 mg
Do.ANDA 071238
Doxepin Hydrochloride (HCl) Capsules USP, EQ 50 mg base
Do.ANDA 071547
Ibuprofen Tablets USP, 800 mg
Do.ANDA 072397
Diazepam Injection USP, 5 mg/mL
Do.ANDA 072407
Fenoprofen Calcium Tablets USP, EQ 600 mg base
Do.ANDA 072602
Fenoprofen Calcium Tablets USP, EQ 600 mg base
Do.ANDA 072630
Albuterol Tablets USP, EQ 4 mg base
Do.ANDA 072825
Baclofen Tablets USP, 20 mg
Do.ANDA 073013
Metaproterenol Sulfate Tablets USP, 10 mg
Do.ANDA 073445
Meperidine HCl Injection USP, 100 mg/mL
Do.ANDA 074025
Guanabenz Acetate Tablets USP, EQ 4 mg base and EQ 8 mg base
Do.ANDA 074114
Dobutamine Injection USP, EQ 12.5 mg base/mL
Do.ANDA 074163
Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg
Do.ANDA 074287
Piroxicam Capsules USP, 10 mg and 20 mg
Do.ANDA 074303
Pentamidine Isethionate for Injection, 300 mg/vial
Do.ANDA 074437
Pindolol Tablets USP, 5 mg and 10 mg
Do.ANDA 074456
Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg
Do.ANDA 077643
Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg
Do.ANDA 080728
Diphenhydramine HCl Capsules USP, 25 mg
Do.ANDA 080968
Dexamethasone Tablets USP, 0.75 mg
Do.ANDA 081040
Chlorzoxazone Tablets USP, 500 mg
Do.ANDA 081149
Hydroxyzine HCl Tablets USP, 10 mg
Do.ANDA 081189
Hydrochlorothiazide Tablets USP, 25 mg
Do.ANDA 081216
Estropipate Tablets USP, 6 mg
Do.ANDA 083232
Hydrochlorothiazide Tablets USP, 50 mg
Do.( print page 49215)ANDA 085720
Meprobamate Tablets USP, 200 mg
Do.ANDA 085721
Meprobamate Tablets USP, 400 mg
Do.ANDA 085778
Hydroxyzine HCl Injection USP, 25 mg/mL
Do.ANDA 086096
Chlorpheniramine Maleate Injection USP, 10 mg/mL
Do.ANDA 086189
Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg
Do.ANDA 086598
Nandrolone Decanoate Injection USP, 100 mg/mL
Do.ANDA 086795
Chlorothiazide Tablets USP, 250 mg
Do.ANDA 087183
Ergoloid Mesylates Sublingual Tablets USP, 1 mg
Do.ANDA 087296
Chlorthalidone Tablets USP, 25 mg
Do.ANDA 087521
Chlorthalidone Tablets USP, 50 mg
Do.ANDA 087772
Prednisone Tablets USP, 50 mg
Do.ANDA 087979
Chloroquine Phosphate Tablets USP, EQ 150 mg base
Do.ANDA 088030
Chloroquine Phosphate Tablets USP, EQ 300 mg base
Do.ANDA 089042
Procainamide HCl Extended-Release Tablets USP, 750 mg
Do.
 Therefore, approval of the applications listed in table 1, and all amendments and supplements thereto, is hereby withdrawn as of November 24, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the 
                    **DATES**
                     section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first. Dated: October 18, 2017. Leslie Kux, Associate Commissioner for Policy.


[FR Doc. 2017-23046 Filed 10-23-17; 8:45 am] BILLING CODE 4164-01-P