Regulatory Updates

FDA has approved ANDA087129 for a 4 mg oral tablet of Cyproheptadine Hydrochloride, sponsored by Strides Pharma Intl, with a history of labeling and manufacturing supplements.

FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.

The FDA approved an ANDA (ANDA077678) for a 0.1% mometasone furoate topical lotion submitted by Cosette Pharms NC; the product is listed as discontinued.

The FDA has approved the ANDA077078 application for metformin hydrochloride 750 mg extended‑release tablets marketed by Zydus Lifesciences.

FDA approved ANDA076788 for a Mometasone Furoate 0.1% topical lotion by Sun Pharma Canada; the product is listed as discontinued, with labeling supplements approved in 2015 and 2019.

FDA has approved ANDA 076507 submitted by TARO for oral Fluconazole tablets in 50‑200 mg strengths; all listed products are marked discontinued.

The FDA approved ANDA 076235 for carboplatin injectable products submitted by Fresenius Kabi USA on Oct 14, 2004. All listed strengths are currently discontinued.

The FDA approved the original ANDA for Glenmark's Mometasone Furoate topical ointment on May 28, 2008, and later granted labeling supplements in 2015 and 2024; the product is now discontinued.

FDA has approved labeling for oral Olmesartan Medoxomil tablets (5 mg, 20 mg, 40 mg) under ANDA 078276 submitted by Rising; the products are listed as discontinued.

The FDA approved Sun Pharm Industries’ ANDA 077975 for oral disintegrating tablets of Donepezil Hydrochloride (5 mg and 10 mg), though both products are listed as discontinued.

Sandoz's generic ophthalmic solution containing 0.05% epinastine hydrochloride has been granted tentative approval by the FDA under ANDA090950.

The FDA lists PROPOXYPHENE COMPOUND-65 oral capsules as discontinued, detailing its active ingredients and a series of manufacturing and labeling submissions from 1976 to 1995.