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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 220308

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NDA 220308 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Barr, Chartwell Rx, Hibrow Hlthcare, Hikma Pharms, Impax Labs, Novitium Pharma, and Zydus Lifesciences, and is included in seven NDAs. It is available from fourteen suppliers. Additional details are available on the FLUDROCORTISONE ACETATE profile page.

The generic ingredient in FLUDROCORTISONE ACETATE is fludrocortisone acetate. There are four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.

Summary for 220308

Tradename:	FLUDROCORTISONE ACETATE
Applicant:	Hibrow Hlthcare
Ingredient:	fludrocortisone acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 220308

Anti-Inflammatory Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Feb 10, 2026	TE:	AB	RLD:	No

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