Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA Approval for Atomoxetine Capsules by Strides Pharma
The FDA approved ANDA 079021 for atomoxetine hydrochloride capsules from Strides Pharma Science, covering strengths from 10 mg to 100 mg.
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Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA212645 for Paroxetine Extended‑Release Tablets
The FDA has approved ANDA212645 for paroxetine extended‑release tablets (12.5 mg, 25 mg, 37.5 mg) marketed by Cadila Pharm Ltd and Modavar Pharmaceuticals.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA210596 for VYDUO Oral Tablet (Nebivolol/Valsartan)
The FDA has approved ANDA210596 for VYDUO, an oral tablet combining nebivolol hydrochloride (5 mg) and valsartan (80 mg), submitted by Prinston Inc.
Regulatory Updates
Sep 16, 2026•1 min read
FDA Approves ANDA203048 for Clindamycin Phosphate Injection by Rising
The FDA granted approval for Rising’s clindamycin phosphate injection products (6, 12, and 18 mg/mL) under application ANDA203048.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA212957 for Fosaprepitant Dimeglumine (Discontinued Product)
The FDA granted approval (status AP) for ANDA212957 submitted by Chartwell Rx for the intravenous powder Fosaprepitant Dimeglumine, which is listed as discontinued.
Regulatory Updates
Sep 12, 2026•1 min read
FDA Approves ANDA 078408 for Vinorelbine Tartrate Injection by Ebewe Pharma
The FDA approved ANDA 078408 for Vinorelbine Tartrate injectable product from Ebewe Pharma. The product is listed as discontinued.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Approves ANDA090572 for Children’s Cetirizine Oral Solutions
FDA approved ANDA090572 submitted by Tris Pharma, covering two discontinued children’s cetirizine hydrochloride oral solutions for allergy and hives relief.
Regulatory Updates
Sep 4, 2026•1 min read
FDA Issues ANDA Approval for STILBESTROL Oral Tablet (Discontinued)
The FDA has approved ANDA083004 for STILBESTROL, an oral tablet containing 0.5 mg diethylstilbestrol, marketed by Tablicaps and listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 084030 for Amosene 400 mg Meprobamate Tablet
The FDA approved ANDA 084030 for the oral tablet Amosene, a 400 mg meprobamate product submitted by FernDale Labs. The listing notes the product as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
World’s First Oral BTK Inhibitor Approved for Chronic Spontaneous Urticaria in Korea
Labsi’s 25 mg twice‑daily oral BTK inhibitor received Korean approval as the first oral therapy for chronic spontaneous urticaria, expanding options beyond injectable second‑line treatments.