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 Grants ANDA216294 Approval for Calcitonin Salmon Injection by Amneal
The FDA has approved the ANDA216294 application for a calcitonin salmon injectable (200 IU/mL) manufactured by Amneal Pharmaceuticals.
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 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 Zydus Lifesciences’ Generic Leflunomide Tablets (ANDA212308)
The FDA has granted approval for Zydus Lifesciences’ generic leflunomide tablets (10 mg and 20 mg) under ANDA212308.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Grants Approval for Ethosuximide 250 mg Oral Capsules (ANDA 211928)
The FDA has approved ANDA 211928 for 250 mg oral capsules of ethosuximide, manufactured by Strides Pharma Science Limited and sponsored by ONESOURCE.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA211272 for Mycophenolate Mofetil Oral Suspension
Teva Pharm USA's ANDA211272 for Mycophenolate Mofetil oral suspension (200 mg/mL) received FDA approval, with several REMS and labeling supplements also approved.
Regulatory Updates
Sep 18, 2026•1 min read
FDA Approves ANDA210929 for Tacrolimus Oral Capsules
FDA has approved application ANDA210929 for tacrolimus oral capsules submitted by Hangzhou Zhongmei Huadong Pharmaceutical, with three discontinued dosage strengths listed.
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 17, 2026•1 min read
FDA Approves Zydus Verapamil Hydrochloride Injection (ANDA214215)
FDA has approved ANDA214215 for Zydus' injectable verapamil hydrochloride (2.5 mg/mL), a prescription IV product for cardiovascular use.
Regulatory Updates
Sep 17, 2026•1 min read
FDA Grants ANDA Approval for ICATIBANT (ANDA213773)
FDA approved ANDA213773 for the subcutaneous injectable prescription drug ICATIBANT, manufactured by Alembic Pharmaceuticals.