Regulatorische Updates

Cipla has an ANDA (application number ANDA077221) for lamivudine tablets in 150 mg and 300 mg strengths, with standard labeling submissions approved in 2019.

Senores Pharms' ANDA090353 for oral Topiramate tablets (25‑200 mg) received FDA approval; all listed products are marked discontinued.

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.

The FDA granted approval (AP) for ANDA 088932 submitted by IVAX PHARMS for an oral tablet containing 0.125 mg reserpine and 50 mg hydroflumethiazide; the product is listed as discontinued.

The FDA has approved ANDA078902 for generic paroxetine hydrochloride tablets (10‑40 mg) manufactured by Mylan Pharmaceuticals.

FDA records indicate Marshall Pharma's oral prednisone 5 mg tablet (product 001) under application ANDA080301 is listed as discontinued.

The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.

FDA approved ANDA 076802 for oral glimepiride tablets in 1 mg, 2 mg and 4 mg strengths; all listed as discontinued after multiple labeling supplements.

The FDA approved IPCA Labs' ANDA090249 for a 500 mg oral chloroquine phosphate tablet in 2009; the product is currently listed as discontinued.

The FDA has approved ANDA084712 for Bethanechol Chloride 10 mg tablets, marketed by Lannett, now listed as discontinued.

FDA has approved Cipla Ltd.'s ANDA077318 for two oral cetirizine hydrochloride allergy tablets (5 mg and 10 mg), both listed as discontinued.

The FDA records show KV Pharm’s oral tablet of Phendimetrazine Tartrate (35 mg) under ANDA 084138 is now listed as discontinued.