Regulatory Updates
FDA, EMA, TGA and global regulatory developments
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Manufacturing and Labeling Submissions for Discontinued Chlorpromazine Tablets
FDA has approved multiple manufacturing and labeling submissions for discontinued chlorpromazine hydrochloride tablets, noting the discontinuations were not due to safety or effectiveness concerns.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Alembic’s Generic Lithium Carbonate Capsules (ANDA 079159)
The FDA has granted approval for Alembic Pharmaceuticals’ generic lithium carbonate oral capsules in 150 mg, 300 mg, and 600 mg strengths under ANDA 079159.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Linezolid 600 mg Tablet (ANDA078845) by Rising Pharma
The FDA has approved ANDA078845 for a 600 mg oral linezolid tablet marketed by Rising Pharma Holdings, Inc.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Discontinues Testosterone Injectable (Product 001) – Submission History
The FDA has marked the testosterone injectable (product 001) as discontinued, with a record of multiple labeling and manufacturing submissions dating back to 1983.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Nitrofurazone Topical Solution (ANDA087081)
The FDA approved ANDA087081 for a 0.2% nitrofurazone topical solution submitted by Wendt; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA085911 for Oxycodone 5/APAP 500 Oral Tablet
FDA approved ANDA085911 for an oral tablet containing 5 mg oxycodone and 500 mg acetaminophen, submitted by Bristol Myers Squibb; the product is listed as discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077941 for Injectable Furosemide (10 mg/mL) by Apotex
The FDA has granted approval (ANDA077941) for Apotex's injectable furosemide 10 mg/mL, classified as a prescription product.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077652 for Levofloxacin Oral Tablets
The FDA has approved ANDA077652 for levofloxacin tablets (250 mg, 500 mg, 750 mg) manufactured by Zydus Lifesciences and Viona Pharmaceuticals.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA077345 for Sertraline Hydrochloride Tablets (Heritage Pharma Avet)
The FDA has approved ANDA077345 submitted by Heritage Pharma Avet for oral sertraline hydrochloride tablets in 25 mg, 50 mg and 100 mg strengths. All listed products are currently marked discontinued.
Regulatory Updates
Sep 19, 2026•1 min read
Ribavirin 200 mg Tablet – FDA ANDA077053 Approval
The FDA approved ANDA077053 for Ribavirin 200 mg oral tablets, sponsored by Heritage Pharma Avet. The product is listed with a discontinued marketing status.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Labeling Submissions for Loxapine Succinate (ANDA076762)
FDA has approved several labeling supplements for the discontinued oral capsule products of Loxapine Succinate under ANDA076762.
Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves Mometasone Furoate Topical Ointment (ANDA076481)
FDA granted approval for ANDA076481, a prescription 0.1% mometasone furoate topical ointment manufactured by Encube Ethicals, Inc.