Regulatory UpdatesAug 31, 2026•1 min read

FDA Approves SUN PHARM Pantoprazole Sodium ANDA077058

By the PharmaCountry team

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.

SUN PHARM has been granted FDA approval for ANDA077058, an Abbreviated New Drug Application for Pantoprazole Sodium oral tablets in a delayed‑release formulation. The application covers two product numbers: 001 (20 mg equivalent base) and 002 (40 mg equivalent base). Both products are listed as discontinued in the FDA database. The submission history includes an original filing (submission 1) approved on 10 September 2007, followed by a series of labeling supplements (submissions 4, 6, 7, 9, 10, 12, 14, 16) approved between 31 August 2009 and 8 April 2015. All labeling supplements were processed under standard review priority. These approvals confirm that SUN PHARM’s Pantoprazole Sodium tablets meet FDA regulatory requirements for labeling, despite the current discontinued marketing status.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#Pantoprazole #ANDA077058 #FDA #SUN PHARM #labeling #oral tablets