Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Ranbaxy Ramipril Capsules (ANDA078849)
FDA approves ANDA078849 submitted by Ranbaxy Labs Ltd for oral ramipril 5 mg and 10 mg capsules, both listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Issues ANDA078545 Approval for Discontinued Lamivudine Tablet Products
The FDA’s ANDA078545 submission by Pharmobedient lists two oral lamivudine tablets (150 mg and 300 mg) that are marked as discontinued, with an approval status dated March 5 2019.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA078249 for Torsemide Tablets by Aurobindo Pharma
The FDA has approved application ANDA078249 for torsemide oral tablets, manufactured by Aurobindo Pharma and Rising Pharma Holdings, covering strengths from 5 mg to 100 mg.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Labeling for Lupin’s Meloxicam Tablets (ANDA 077944)
The FDA’s database lists ANDA 077944 for meloxicam tablets (7.5 mg and 15 mg) by Lupin Pharmaceuticals, with several labeling submissions approved; the products are currently marked discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA077655 for VALACYCLOVIR HYDROCHLORIDE Tablets
FDA has approved ANDA077655 for valacyclovir hydrochloride oral tablets (500 mg and 1 g) from Teva Pharm, with original and supplemental labeling approvals.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 077351 for Multiple Oral Acid‑Reducer Brands
The FDA has approved ANDA 077351, covering a range of oral acid‑reducer and heartburn‑prevention products listed under various brand names.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Labeling Supplements for Discontinued Escitalopram Oxalate Tablets (ANDA 076765)
The FDA has approved several labeling supplement submissions for discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) under ANDA 076765.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA 076484 for Ciprofloxacin Injectable Products by Fresenius Kabi USA
The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Apotex Sotalol Hydrochloride Tablets (ANDA 076214)
The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA081029 for Quinidine Sulfate Tablets by Sun Pharm Industries
Sun Pharm Industries received FDA approval for an ANDA (ANDA081029) covering oral quinidine sulfate tablets (100 mg). The product is listed as discontinued, with multiple supplemental approvals for manufacturing and labeling.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA080445 for Meperidine Hydrochloride Injectable Products
The FDA has granted approval for ANDA080445, covering multiple injectable strengths of meperidine hydrochloride manufactured by Hikma Pharmaceuticals USA.
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Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves ANDA079162 for Topiramate Generic Tablets
The FDA has approved application ANDA079162 for generic topiramate oral tablets (25 mg, 50 mg, 100 mg, 200 mg) manufactured by Cipla USA Inc. and Exelan Pharmaceuticals.