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 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 9, 2026•1 min read
FDA Approves Oxford Pharm Generic Simvastatin Tablets (ANDA078735)
FDA has approved Oxford Pharm's abbreviated new drug application for generic simvastatin tablets in five strengths, all prescription oral products.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves Lupin Generic Levetiracetam Tablets (ANDA 078154)
The FDA has approved Lupin Pharmaceuticals’ generic levetiracetam tablets in 250 mg, 500 mg, and 750 mg oral strengths under ANDA 078154.
Regulatory Updates
Sep 9, 2026•1 min read
FDA Approves ANDA077850 for Nicotine Polacrilex Buccal Gum
FDA granted approval for ANDA077850, a generic nicotine polacrilex buccal gum (4 mg base) by IVAX Sub Teva Pharms, with labeling supplements approved in 2012 and 2013.
Regulatory Updates
Sep 8, 2026•1 min read
Marshall Pharma Prednisone Tablet (5 mg) ANDA080301 Discontinued
FDA records indicate Marshall Pharma's oral prednisone 5 mg tablet (product 001) under application ANDA080301 is listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA086088 for Hydralazine Hydrochloride Oral Tablet (Discontinued)
The FDA has listed ANDA086088 for Hydralazine Hydrochloride 25 mg oral tablets submitted by Vitarine, noting the product is discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA090265 for Hydrocodone/Acetaminophen Tablets
The FDA's ANDA090265, submitted by CARACO, received approval on Dec 23, 2008 for three oral hydrocodone bitartrate/acetaminophen tablet strengths, now listed as discontinued.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves ANDA077766 for Simvastatin Generic Tablets
The FDA granted approval for Chartwell Rx's ANDA077766, covering five discontinued Simvastatin tablet strengths and subsequent labeling updates.
Regulatory Updates
Sep 8, 2026•1 min read
FDA Approves Labeling for Teva’s Discontinued Ramipril Capsules (ANDA 077470)
Teva Pharmaceuticals’ oral ramipril capsule products (1.25‑10 mg) were listed as discontinued, with multiple FDA labeling supplements approved between 2008 and 2014.
Regulatory Updates
Sep 5, 2026•1 min read
FDA Approves Sandoz DRALSERP Tablet (Hydralazine HCl/Reserpine) – ANDA084617
The FDA approved Sandoz's ANDA084617 for the oral tablet DRALSERP containing hydralazine hydrochloride 25 mg and reserpine 0.1 mg; the product is listed as discontinued.