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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
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Response Letter
Response Letter
Nonrulemaking
Other
FDA-2026-P-1308-0007
Pharmaceutical Policy
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The document's own metadata, straight from regulations.gov.
Posted
Jun 4, 2026
Agency
Food and Drug Administration (FDA)
