Regulatory UpdatesSep 9, 2026•1 min read

FDA Approves ANDA089116 for BROMPHERIL Extended-Release Tablet

By the PharmaCountry team

FDA approved ANDA089116 for BROMPHERIL, an oral extended-release tablet containing 6 mg dexbrompheniramine maleate and 120 mg pseudoephedrine sulfate, submitted by Copley Pharm; product is listed as discontinued.

The U.S. Food and Drug Administration has granted approval for application number ANDA089116 covering the product BROMPHERIL. BROMPHERIL is an oral tablet in an extended‑release formulation. Each tablet contains 6 mg of dexbrompheniramine maleate and 120 mg of pseudoephedrine sulfate. The dosage form is identified as “TABLET, EXTENDED RELEASE.” The FDA record indicates the product’s marketing status is “Discontinued.” The sponsor for this application is Copley Pharm. The submission timeline includes an original submission (submission 1) approved on 22 January 1987, followed by numerous supplemental submissions—both manufacturing (CMC) and labeling—approved between 1988 and 1999. The latest manufacturing CMC supplement (submission 12) received approval on 17 June 1999. No reference drug or reference standard was cited for BROMPHERIL in the FDA filing.

Compiled by the PharmaCountry team · Source: FDA.gov

Topics:#FDA #ANDA #BROMPHERIL #extended release #Oral Tablet #pharmaceutical regulation