Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves SUN PHARM Fluconazole Oral Suspension ANDA 076332
FDA approved Sun Pharm Industries Ltd's ANDA 076332 for Fluconazole oral suspension (200 mg/5 mL and 50 mg/5 mL). Both products are now discontinued.
Regulatory Updates
Sep 25, 2026•1 min read
FDA Approves Labeling for Sun Pharm Amlodipine Besylate (ANDA078081)
FDA approved a labeling supplement for Sun Pharm's amlodipine besylate tablets (2.5 mg, 5 mg, 10 mg) under ANDA078081; the products are currently listed as discontinued.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sun Pharm ANDA077373 for Octreotide Acetate Injectable Products
FDA granted approval for Sun Pharm's ANDA077373 covering two discontinued octreotide acetate injectable products, with labeling updates approved in 2013 and 2017.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Approves Sun Pharm’s Donepezil Hydrochloride ORAL Tablets (ANDA 077975) – Discontinued Products
The FDA approved Sun Pharm Industries’ ANDA 077975 for oral disintegrating tablets of Donepezil Hydrochloride (5 mg and 10 mg), though both products are listed as discontinued.
Regulatory Updates
Sep 3, 2026•1 min read
FDA Approves ANDA 076576 for Sotalol Hydrochloride Tablets by Sun Pharm Industries
The FDA approved application ANDA076576 for oral Sotalol Hydrochloride tablets (80 mg, 120 mg, 160 mg) from Sun Pharm Industries; all listed products are marked discontinued.
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.