Regulatory Updates

The FDA granted approval for ANDA 088622, an oral 50 mg Amitriptyline Hydrochloride tablet submitted by Watson Labs; the product is listed as discontinued.

The FDA approved Teva’s ANDA 088923 for a 50 mg oral hydrochlorothiazide tablet; the product is listed as discontinued.

FDA grants approval for ANDA088292, an oral imipramine hydrochloride tablet by Strides Pharma Science Limited, with details on dosage, NDC codes, and submission history.

The FDA has granted approval for Teva Pharmaceuticals' generic carvedilol oral tablets, covering strengths from 3.125 mg to 25 mg under ANDA 076373.

The FDA approved SUN Pharma Canada's ANDA077227 for a topical 0.05% halobetasol propionate cream; the product is currently listed as discontinued.

FDA approved Hikma International Pharmaceutics' generic lithium carbonate 300 mg tablet (ANDA 078715) on Dec 28 2010, with a labeling supplement approved in 2012.

The FDA granted approval (ANDA 086865) for Watson Labs' oral chlorpropamide 100 mg tablet, which is currently listed as discontinued.

FDA has approved ANDA078976 for Levetiracetam oral solution, a prescription drug manufactured by Actavis Pharma, Inc., with a detailed submission history.

Solubiomix received FDA approval for ANDA 076329 for a prescription topical lotion containing 0.1% amcinonide.

The FDA has approved the ANDA for REVONTO, a 20 mg/vial injectable dantrolene sodium product from USWM, LLC, for prescription use.

The FDA approved ANDA080711 for a procaine hydrochloride injectable product by BEL MAR. The original submission was approved on Dec 3 1973 and the product is listed as discontinued.

FDA approved Lilly's ANDA080256 for methyltestosterone tablets (10 mg and 25 mg) buccal/sublingual on Dec 22 1971; both products are now discontinued.