Requests that the FDA declare that Hydrocortisone Tablets, 2.5 mg, 7.5 mg, and 15 mg, are suitable for submission as an ANDA. As designated in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) the Reference Listed Drug (RLD) upon which this petition is based is Pharmacia & Upjohn Co.s (Pfizer, Inc.s) CORTEF (hydrocortisone) Tablets, which is approved for
🏛 Food and Drug Administration (FDA)FDA-2026-P-1308
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