Regulatory Updates
Sep 19, 2026•1 min read
FDA Approves ANDA 084553 for COMPOUND 65 Oral Capsule
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.
Regulatory Updates
Sep 15, 2026•1 min read
FDA Discontinues Propoxyphene Compound-65 Oral Capsule
The FDA lists PROPOXYPHENE COMPOUND-65 oral capsules as discontinued, detailing its active ingredients and a series of manufacturing and labeling submissions from 1976 to 1995.
Regulatory Updates
Sep 11, 2026•1 min read
FDA Approves ANDA076609 for Propoxyphene Napyslate/Acetaminophen Tablet
The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.
Regulatory Updates
Aug 30, 2026•1 min read
Mylan Discontinues Propoxyphene Hydrochloride 32 mg Oral Capsule (ANDA083528)
Mylan’s ANDA083528 for propoxyphene hydrochloride 32 mg oral capsules is listed as discontinued by the FDA.
Regulatory Updates
Aug 29, 2026•1 min read
FDA Approves ANDA083089 for Propoxyphene Hydrochloride Capsules (Roxane)
FDA granted approval for ANDA083089 covering two oral capsule strengths of propoxyphene hydrochloride by Roxane; both products are listed as discontinued.