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Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of December 10, 2018.

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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,

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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.Start Printed Page 56087

Application No.DrugApplicant
ANDA 040747Benzphetamine Hydrochloride (HCl) Tablets, 25 milligrams (mg) and 50 mgTedor Pharma, Inc., 400 Highland Corporate Dr., Cumberland, RI 02864.
ANDA 062356Gentamicin Sulfate Injection USP, Equivalent to (EQ) 10 mg base/milliliter (mL) and EQ 40 mg base/mLFresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 074097Isoflurane USP, 99.9%Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
ANDA 076484Ciprofloxacin Injection USP, 200 mg/20 mL and 400 mg/40 mLFresenius Kabi USA, LLC.
ANDA 080504Epinephrine and Lidocaine HCl Injection, 0.01 mg/mL; 2% and 0.02 mg/mL; 2% Lidocaine HCl Injection, 2%.Belmora LLC, 2231 Crystal Dr., #1000, Arlington, VA 22202.
ANDA 083559Mepivacaine HCl Injection, 3%Do.
ANDA 084315Dexamethasone Acetate Injectable Suspension USP, EQ 8 mg base/mLWatson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 084850Levonordefrin and Mepivacaine HCl Injection, 2%; 0.05 mg/mLBelmora LLC.
ANDA 086389Lidocaine HCl Viscous Oral Topical Solution USP, 2%International Medication Systems, Ltd., 1886 Santa Anita Ave., South El Monte, CA 91733.
ANDA 087863Choledyl SA (oxtriphylline) Extended-Release Tablets USP, 400 mgWarner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of December 10, 2018. 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 the table that are in inventory on December 10, 2018 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.

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Dated: November 6, 2018.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2018-24605 Filed 11-8-18; 8:45 am]