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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 091302

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NDA 091302 describes FLUDROCORTISONE ACETATE, which is a drug marketed by Barr, Chartwell Rx, Hikma Pharms, Impax Labs, and Novitium Pharma, and is included in five NDAs. It is available from twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.

Summary for 091302

Tradename:	FLUDROCORTISONE ACETATE
Applicant:	Hikma Pharms
Ingredient:	fludrocortisone acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 091302

Anti-Inflammatory Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.1MG
Approval Date:	Jul 22, 2011	TE:		RLD:	No

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