Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves Prilosec (Omeprazole) NDA 019810 Submissions
FDA approved several manufacturing and labeling submissions for Prilosec (omeprazole) products under NDA 019810, including priority reviews for 10 mg, 20 mg and 40 mg strengths.
Regulatory Updates
Aug 31, 2026•1 min read
FDA Approves Multiple Submissions for CYCLOCORT Topical Cream (NDA018116)
The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.
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 SUN PHARM Pantoprazole Sodium ANDA077058
SUN PHARM received FDA approval for ANDA077058 covering Pantoprazole Sodium delayed‑release tablets (20 mg and 40 mg). Multiple labeling supplements were approved between 2009 and 2015.
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 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
Daewoong Bio Revamps Prescription Drug Packaging Following MFDS Safety Initiative
Daewoong Bio is redesigning packaging for its entire prescription line to improve visual identification and reduce compounding errors, aligning with the MFDS’s July push for safer drug labeling.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves Zydus Generic Galantamine Hydrobromide Tablets (ANDA078898)
FDA has approved ANDA078898 for Zydus Pharm's oral galantamine hydrobromide tablets (4 mg, 8 mg, 12 mg) with standard labeling submissions.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Grants Approval for Prednisolone 5 mg Tablet (ANDA 080531) by Chartwell RX
The FDA approved application ANDA080531 for a 5 mg oral prednisolone tablet marketed by Chartwell RX, LLC, with multiple manufacturing and labeling supplements authorized.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ORSYTHIA (ANDA077099) Oral Tablet
FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.
Regulatory Updates
Aug 30, 2026•1 min read
FDA Approves ANDA078299 for Ketorolac Tromethamine Injectable Products
The FDA has approved ANDA078299 for Ketorolac Tromethamine injectable (15 mg/mL and 30 mg/mL) from Onesource Specialty, with labeling updates; both products are marked discontinued.
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