| Page Range | 49214-49215 | |
| FR Document | 2017-23046 |
[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)] [Notices] [Pages 49214-49215] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-23046] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5715] Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of November 24, 2017.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 Sec. 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 Sec. 314.150(c) is without prejudice to refiling. Table 1 ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ ANDA 061717.................. Doxycycline Hyclate Watson Capsules USP, Laboratories, Equivalent to (EQ) Inc., Subsidiary 50 milligrams (mg) of Teva base and EQ 100 mg Pharmaceuticals base. USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 062087.................. Erythromycin Do. Estolate Capsules USP, EQ 250 mg base. ANDA 062318.................. Gentamicin Injection Do. USP, EQ 10 mg base/ milliliter (mL) and EQ 40 mg base/mL. ANDA 062816.................. Ampicillin for Do. 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. ANDA 062994.................. Ampicillin for Do. Injection USP, EQ 10 g base/vial. ANDA 062999.................. Erythromycin Delayed- Barr Laboratories, Release Tablets Inc., Subsidiary USP, 500 mg. of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 064036.................. Cefuroxime for Watson Injection USP, EQ Laboratories, 7.5 g base/vial. Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 070296.................. Diazepam Injection Do. USP, 5 mg/mL. ANDA 070412.................. Furosemide Tablets Do. USP, 20 mg. ANDA 070435.................. Ibuprofen Tablets Do. USP, 200 mg. ANDA 070436.................. Ibuprofen Tablets Do. USP, 400 mg. ANDA 070437.................. Ibuprofen Tablets Do. USP, 600 mg. ANDA 070449.................. Furosemide Tablets Do. USP, 20 mg. ANDA 070450.................. Furosemide Tablets Do. USP, 40 mg. ANDA 070515.................. Tolazamide Tablets Do. USP, 500 mg. ANDA 070528.................. Furosemide Tablets Do. USP, 80 mg. ANDA 071238.................. Doxepin Do. Hydrochloride (HCl) Capsules USP, EQ 50 mg base. ANDA 071547.................. Ibuprofen Tablets Do. USP, 800 mg. ANDA 072397.................. Diazepam Injection Do. USP, 5 mg/mL. ANDA 072407.................. Fenoprofen Calcium Do. Tablets USP, EQ 600 mg base. ANDA 072602.................. Fenoprofen Calcium Do. Tablets USP, EQ 600 mg base. ANDA 072630.................. Albuterol Tablets Do. USP, EQ 4 mg base. ANDA 072825.................. Baclofen Tablets Do. USP, 20 mg. ANDA 073013.................. Metaproterenol Do. Sulfate Tablets USP, 10 mg. ANDA 073445.................. Meperidine HCl Do. Injection USP, 100 mg/mL. ANDA 074025.................. Guanabenz Acetate Do. Tablets USP, EQ 4 mg base and EQ 8 mg base. ANDA 074114.................. Dobutamine Injection Do. USP, EQ 12.5 mg base/mL. ANDA 074163.................. Naproxen Tablets Do. USP, 250 mg, 375 mg, and 500 mg. ANDA 074287.................. Piroxicam Capsules Do. USP, 10 mg and 20 mg. ANDA 074303.................. Pentamidine Do. Isethionate for Injection, 300 mg/ vial. ANDA 074437.................. Pindolol Tablets Do. USP, 5 mg and 10 mg. ANDA 074456.................. Alprazolam Tablets Do. USP, 0.25 mg, 0.5 mg, and 1 mg. ANDA 077643.................. Topiramate Tablets Do. USP, 25 mg, 50 mg, 100 mg, and 200 mg. ANDA 080728.................. Diphenhydramine HCl Do. Capsules USP, 25 mg. ANDA 080968.................. Dexamethasone Do. Tablets USP, 0.75 mg. ANDA 081040.................. Chlorzoxazone Do. Tablets USP, 500 mg. ANDA 081149.................. Hydroxyzine HCl Do. Tablets USP, 10 mg. ANDA 081189.................. Hydrochlorothiazide Do. Tablets USP, 25 mg. ANDA 081216.................. Estropipate Tablets Do. USP, 6 mg. ANDA 083232.................. Hydrochlorothiazide Do. Tablets USP, 50 mg. [[Page 49215]] ANDA 085720.................. Meprobamate Tablets Do. USP, 200 mg. ANDA 085721.................. Meprobamate Tablets Do. USP, 400 mg. ANDA 085778.................. Hydroxyzine HCl Do. Injection USP, 25 mg/mL. ANDA 086096.................. Chlorpheniramine Do. Maleate Injection USP, 10 mg/mL. ANDA 086189.................. Ergoloid Mesylates Do. Sublingual Tablets USP, 0.5 mg. ANDA 086598.................. Nandrolone Decanoate Do. Injection USP, 100 mg/mL. ANDA 086795.................. Chlorothiazide Do. Tablets USP, 250 mg. ANDA 087183.................. Ergoloid Mesylates Do. Sublingual Tablets USP, 1 mg. ANDA 087296.................. Chlorthalidone Do. Tablets USP, 25 mg. ANDA 087521.................. Chlorthalidone Do. Tablets USP, 50 mg. ANDA 087772.................. Prednisone Tablets Do. USP, 50 mg. ANDA 087979.................. Chloroquine Do. Phosphate Tablets USP, EQ 150 mg base. ANDA 088030.................. Chloroquine Do. Phosphate Tablets USP, EQ 300 mg base. ANDA 089042.................. Procainamide HCl Do. Extended-Release Tablets USP, 750 mg. ------------------------------------------------------------------------ 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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of November 24, 2017. | |
| 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. | |
| FR Citation | 82 FR 49214 |