Regulatory UpdatesSep 19, 2026•1 min read

FDA Approves ANDA 084553 for COMPOUND 65 Oral Capsule

By the PharmaCountry team

FDA approved ANDA 084553 for COMPOUND 65, an oral capsule containing aspirin 389 mg, caffeine 32.4 mg, and propoxyphene HCl 65 mg; sponsor ALRA; product listed as discontinued.

The U.S. Food and Drug Administration has approved ANDA 084553 for the product COMPOUND 65. COMPOUND 65 is an oral capsule (product number 002) that contains aspirin 389 mg, caffeine 32.4 mg, and propoxyphene hydrochloride 65 mg per dosage unit. The product is listed as discontinued in marketing status. The sponsor for the application is ALRA. The original submission (type ORIG, number 1) received approval on 23 September 1975. Subsequent supplemental submissions (numbers 15 and 17) related to manufacturing (CMC) were approved on 28 April 1983 and 17 August 1983 respectively.

Compiled by the PharmaCountry team · Source: FDA.gov