Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sun Pharma Canada ANDA for Mometasone Furoate Topical Lotion
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves ANDA 076507 for Fluconazole Tablets
FDA has approved ANDA 076507 submitted by TARO for oral Fluconazole tablets in 50‑200 mg strengths; all listed products are marked discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
Glenmark Pharm's Mometasone Furoate Ointment (ANDA078571) Receives Multiple Labeling Approvals
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Grants Labeling Approval for Olmesartan Medoxomil Tablets (ANDA 078276)
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Propoxyphene Compound-65 Oral Capsule
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Multiple Labeling Supplements for MirtaZAPINE (ANDA 076901)
FDA's ANDA 076901 for MirtaZAPINE includes three discontinued oral tablet strengths and a series of approved labeling supplements dating from 2005 to 2025.
Regulatory Updates
Sep 13, 2026•1 min read
FDA Approves ANDA 077105 for Valproic Acid Oral Syrup
FDA has approved multiple labeling supplements for the discontinued VALPROIC ACID oral syrup (ANDA 077105). Original approval dates to 2005.
Regulatory Updates
Sep 12, 2026•1 min read
ANI PHARMS Diflorasone Diacetate Cream (ANDA076263) Discontinued
ANI PHARMS' diflorasone diacetate 0.05% topical cream (product 001) is listed as discontinued in FDA records. Multiple labeling submissions under ANDA076263 have been approved.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Mellaril‑S Oral Suspension (NDA 017923)
The FDA has approved several manufacturing (CMC) and labeling submissions for the discontinued oral suspension Mellaril‑S, containing thioridazine, under NDA 017923.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA077545 for Ondansetron Hydrochloride Tablets
FDA approved application ANDA077545 from Hikma International Pharmaceuticals for discontinued oral ondansetron tablets (4 mg, 8 mg, 24 mg) with multiple labeling supplements approved.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Labeling and REMS Submissions for Discontinued OxyMorphone Hydrochloride ER Tablets (ANDA 079046)
The FDA records show OxyMorphone Hydrochloride extended‑release tablets are discontinued, yet several labeling and REMS submissions for the product have been approved.
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Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves Labeling for ORETON Buccal Tablet (Methyltestosterone 10 mg) – ANDA080281
The FDA approved labeling for SCHERING's ORETON buccal tablet containing 10 mg methyltestosterone (application ANDA080281). The product is listed as discontinued.