The Food and Drug Administration (FDA) has approved the Abbreviated New Drug Application (ANDA) number 081095 submitted by MIKART. The application concerns an oral capsule product containing 150 mg acetaminophen, 180 mg aspirin, and 15 mg codeine phosphate.
The approval covers several submissions: an original filing (ORIG) approved on 1990‑10‑26, labeling (SUPPL) approved on 1991‑12‑09, and multiple manufacturing (CMC) supplements approved on 1991‑12‑09 and 1998‑07‑31.
According to the FDA record, the product’s marketing status is listed as discontinued, and it is not designated as a reference drug or reference standard.
Actualizaciones regulatorias16 sept 2026•3 min de lectura
FDA Approves ANDA081095 for Oral Acetaminophen/Aspirin/Codeine Capsule (Discontinued)
The FDA granted approval for labeling and manufacturing submissions for ANDA081095, a discontinued oral capsule combining acetaminophen, aspirin, and codeine phosphate, sponsored by MIKART.
Recopilado por el equipo de Pharmacountry · Fuente: FDA.gov
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