The U.S. Food and Drug Administration has granted approval for Sun Pharm Industries’ Abbreviated New Drug Application (ANDA) 077975 covering oral disintegrating tablets of Donepezil Hydrochloride. The application includes two product entries: product number 001 (10 mg) and product number 002 (5 mg), both classified as oral tablets, orally disintegrating, and currently marked as discontinued.
Submission records show an original (ORIG) filing that received approval on December 11, 2009. Supporting documents include a label (dated April 19, 2011) and an approval letter (dated December 24, 2009). Subsequent supplemental (SUPPL) submissions for labeling were approved on February 16, 2011 for both submission numbers 1 and 2.
Sun Pharm Industries is listed as the sponsor for this ANDA. While the FDA approval is on record, the marketing status for both Donepezil Hydrochloride tablet strengths remains discontinued.
Regulatory UpdatesSep 15, 2026•3 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.
Compiled by the Pharmacountry team · Source: FDA.gov
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