Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Sevelamer Hydrochloride Generic (ANDA 206883) by Macleods Pharmaceuticals
The FDA has approved the generic drug Sevelamer Hydrochloride (ANDA 206883) from Macleods Pharmaceuticals, available as 400 mg and 800 mg oral tablets.
Regulatory Updates
Sep 10, 2026•1 min read
FDA approves ANDA090609 for atomoxetine capsules by Dr. Reddy's Laboratories
FDA has granted approval for ANDA090609, allowing Dr. Reddy's Laboratories to market generic atomoxetine hydrochloride oral capsules in multiple strengths.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Discontinues Oral Prednisolone Tablet (ANDA083675)
The FDA has listed the oral prednisolone 5 mg tablet (product 001) from sponsor Bundy as discontinued under ANDA083675.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Lists Watson Labs' COBAVITE Injection (ANDA083064) as Discontinued
FDA records indicate that Watson Labs' injectable product COBAVITE, containing 1 mg/mL cyanocobalamin, is listed as discontinued under ANDA083064.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA080718 for Thiamine Hydrochloride Injection (Discontinued)
The FDA granted approval (ANDA080718) for BEL MAR's thiamine hydrochloride injectable product, listed as discontinued.
1
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA078384 for Carvedilol Tablets by Unichem Pharmaceuticals
The FDA has approved ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Chartwell Molecular Lamotrigine Tablet ANDA077783
FDA has approved ANDA 077783 for oral lamotrigine tablets (25‑200 mg) submitted by Chartwell Molecular, with multiple labeling submissions cleared.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves Amici Pharma’s Generic Pravastatin Sodium Tablets (ANDA 077491)
The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.
Regulatory Updates
Sep 10, 2026•1 min read
MEPROBAMATE (ANDA 085721) Discontinued Oral Tablet – FDA
FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.
Regulatory Updates
Sep 10, 2026•1 min read
FDA ANDA084751 Approval for DILOR-400 (400 mg Theophylline)
DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.
Regulatory Updates
Sep 10, 2026•1 min read
FDA Approves ANDA 076335 for TRI-PREVIFEM Oral Tablet
The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.
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.