Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA081069 for Hydrocodeine Bitartrate and Acetaminophen Oral Capsule
The FDA approved ANDA081069 for an oral capsule containing 5 mg hydrocodeine bitartrate and 500 mg acetaminophen, sponsored by Mikart. The product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA080482 for C & M Pharma’s Hydrocortisone Creams (Discontinued)
The FDA granted approval (ANDA080482) to C & M Pharma for two topical hydrocortisone cream products, both now listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA083442 for Meprobamate 400mg Oral Tablet
The FDA approved ANDA083442 for a 400 mg oral tablet of meprobamate submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Primaquine Phosphate (NDA008316)
The FDA has approved Primaquine Phosphate, an oral prescription tablet (NDA008316) from Sanofi‑Aventis U.S. LLC, with recent labeling updates in 2025.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA088262 for Imipramine Hydrochloride Tablets by Strides Pharma
The FDA has approved the ANDA for Imipramine Hydrochloride 25 mg oral tablets (brand name IMIPRAMINE HYDROCHLORIDE) manufactured by Strides Pharma Science Limited, with the latest labeling approval on May 1 2023.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Multiple Supplemental Submissions for Phentermine Hydrochloride (ANDA 088596)
The FDA has approved a series of supplemental labeling and manufacturing submissions for the discontinued oral tablet Phentermine Hydrochloride (37.5 mg) under ANDA 088596.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077672 for Stavudine Capsules by Aurobindo Pharma
FDA has approved labeling submissions for ANDA077672 covering stavudine oral capsules from Aurobindo Pharma; all listed products are marked discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Over-the-Counter Famotidine ANDA077367 for Dr. Reddy's Labs
The FDA has granted approval for an over‑the‑counter famotidine tablet (10 mg and 20 mg) under ANDA 077367, sponsored by Dr. Reddy’s Laboratories Ltd.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues UTICORT Topical Lotion (NDA017528)
The FDA record shows UTICORT lotion, a 0.025% betamethasone benzoate topical product by Parke‑Davis, is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA NDA006920: Lederle's Triple Sulfas Oral Products Listed as Discontinued
The FDA’s NDA006920 for Lederle’s oral drug Triple Sulfas includes two discontinued formulations—a suspension and a tablet—both containing trisulfapyrimidines, sulfamerazine, and sulfamethazine.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Lists Fexofenadine Hydrochloride Products Under ANDA076502
The FDA database shows multiple oral tablet products of Fexofenadine Hydrochloride under application ANDA076502, with strengths from 30 mg to 180 mg, some discontinued and others OTC.
1
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Sandoz OFLOXACIN Ophthalmic Solution (ANDA 076231)
The FDA approved Sandoz's ANDA 076231 for a 0.3% OFLOXACIN ophthalmic solution, though the product is listed as discontinued.