Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA078127 for Ondansetron Oral Solution
The FDA has approved application ANDA078127 for an oral ondansetron solution (4 mg/5 mL) marketed by PAI Holdings, LLC dba PAI Pharma.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA077826 for Fenoldopam Mesylate Injection
The FDA has approved an Abbreviated New Drug Application (ANDA077826) for fenoldopam mesylate injection submitted by Teva Parenteral.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Teva Olanzapine/Fluoxetine Combination (ANDA077528)
FDA has approved Teva Pharmaceuticals' ANDA077528 for an oral capsule combining olanzapine and fluoxetine, with several dosage strengths, as of Feb 26 2021.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves Carvedilol Generic (ANDA 076649) by Dr. Reddy's Laboratories
FDA granted approval for ANDA 076649, a carvedilol oral tablet generic from Dr. Reddy's Laboratories, covering four strengths and prescription use.
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 Hikma’s Indomethacin Sodium Injection (ANDA 078713)
The FDA has approved ANDA 078713 for Hikma’s injectable Indomethacin Sodium, though the product is listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA078416 for Prednisolone Sodium Phosphate Oral Solution
The FDA granted approval (status AP) for Vintage Pharms' ANDA078416 covering an oral solution of prednisolone sodium phosphate on Oct 31 2007; the product is listed as discontinued.
Regulatory Updates
Sep 18, 2026•1 min read
Lupin Ltd Submits Original ANDA216716 to FDA – Tentative Approval
Lupin Ltd filed an original ANDA (application number ANDA216716) with the FDA, currently listed as Tentative Approval as of August 13, 2024.
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Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves AUVELITY Extended-Release Tablet (NDA 215430)
The FDA has approved AUVELITY, an oral extended‑release tablet combining bupropion hydrochloride and dextromethorphan hydrobromide under NDA 215430.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants ANDA Approval for Voriconazole Injection (ANDA220043)
The FDA approved an ANDA for Voriconazole injection, a 10 mg/mL intravenous antifungal solution, sponsored by Hainan Poly Pharm.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Tentative Approval for Dapagliflozin Tablets (ANDA219408)
Sciegen Pharmaceuticals received tentative FDA approval for 5 mg and 10 mg dapagliflozin tablets under ANDA219408.
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Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Priority Approval to EPIZYME’s Orphan Drug TAZVERIK (TAZEMETOSTAT HYDROBROMIDE 200 mg)
The FDA approved TAZVERIK, a prescription oral tablet for EPIZYME Inc., under NDA 213400 with priority review and orphan designation.