Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216013

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NDA 216013 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 fifteen suppliers. Additional details are available on the FLUDROCORTISONE ACETATE profile page.

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

Summary for 216013

Tradename:	FLUDROCORTISONE ACETATE
Applicant:	Chartwell Rx
Ingredient:	fludrocortisone acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 216013

Anti-Inflammatory Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Oct 27, 2022	TE:		RLD:	No

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