The U.S. Food and Drug Administration (FDA) issued an approval for ANDA084351 on December 17, 1975. The application was submitted by IVAX Sub Teva Pharm and pertains to an oral tablet containing 4 mg of brompheniramine maleate.
The product is identified as a tablet dosage form, administered via the oral route. It is listed under product number 001 and is not a reference drug. The FDA’s record indicates the marketing status of the product as discontinued.
The submission was an original (ORIG) filing, submission number 1, and received an approval status (AP) on the aforementioned date.
Regulatory UpdatesAug 30, 2026•3 min read
FDA Approves ANDA084351 for Brompheniramine Maleate 4 mg Tablet (Now Discontinued)
The FDA granted approval (ANDA084351) for a 4 mg oral tablet of brompheniramine maleate by IVAX Sub Teva Pharm; the product is currently listed as discontinued.
Compiled by the Pharmacountry team · Source: FDA.gov
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