Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA077182 for Desogestrel/Ethinyl Estradiol Oral Tablets
The FDA has approved ANDA077182 submitted by Dr. Reddys Labs SA for prescription oral tablets containing desogestrel and ethinyl estradiol, including multiple dosage strengths.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANI PHARMS' Fosinopril/HCTZ Tablets (ANDA 076608)
The FDA approved labeling submissions for ANI PHARMS' fosinopril sodium and hydrochlorothiazide oral tablets under ANDA 076608.
Regulatory Updates
Sep 10, 2026•1 min read
FDA NDA 007883: Antabuse (disulfiram) supplemental manufacturing and labeling submissions
The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Lists Two Discontinued Fluconazole Injection Products Under ANDA 076889
FDA’s ANDA 076889 lists two injectable fluconazole products from Mylan Labs, both marked as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
CAM-METRAZINE (ANDA085320) Discontinued Oral Tablet by Chartwell Rx
Chartwell Rx’s oral tablet CAM-METRAZINE, containing 35 mg phendimetrazine tartrate, is listed as discontinued. The FDA ANDA record shows multiple manufacturing and labeling submissions.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Issues ANDA Approval for Watson Labs' Procaineamide Hydrochloride Oral Capsule (ANDA083795)
The FDA has approved an ANDA (ANDA083795) for Watson Labs' oral capsule containing 250 mg of procaineamide hydrochloride. The product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Multiple Submissions for Lidocaine Hydrochloride Injection (Discontinued Product)
The FDA has approved several labeling and manufacturing submissions for the discontinued injectable lidocaine hydrochloride (2%) product.
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Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA080800 for Diphenhydramine Hydrochloride Oral Capsule
FDA granted approval for ANDA080800, a 50 mg diphenhydramine hydrochloride oral capsule submitted by Whiteworth Town Plsn; the product is listed as discontinued.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Mylan Nisoldipine Extended‑Release Tablets (ANDA 079051) – Discontinued Products
The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Discontinues Oral Prednisone 5mg Tablet (ANDA080300)
The FDA has listed the oral prednisone 5 mg tablet (product 001) from sponsor HALSEY as discontinued under application ANDA080300.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves IMPAX Labs' ACARBOSE Oral Tablets (ANDA 078441)
FDA granted approval for IMPAX Labs' ANDA 078441, authorizing prescription oral tablets of ACARBOSE in 25 mg, 50 mg, and 100 mg strengths.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Announces Discontinuation of Watson Labs Potassium Chloride Injection (ANDA 086210)
The FDA records show that Watson Labs' potassium chloride injectable (3 mEq/mL) under ANDA 086210 is listed with a discontinued marketing status.