Actualizaciones regulatorias
Novedades regulatorias de FDA, EMA, TGA y organismos globales
#Propoxyphene ×
Actualizaciones regulatorias
19 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
15 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
11 sept 2026•1 min de lectura
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.
Actualizaciones regulatorias
30 ago 2026•1 min de lectura
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.
Actualizaciones regulatorias
29 ago 2026•1 min de lectura
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.
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