Last Updated: May 11, 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 fifteen 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. Fifteen 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

Suppliers and Packaging for NDA: 220308

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUDROCORTISONE ACETATE	fludrocortisone acetate	TABLET;ORAL	220308	ANDA	Eywa Pharma Inc	71930-088	71930-088-12	100 TABLET in 1 BOTTLE (71930-088-12)
FLUDROCORTISONE ACETATE	fludrocortisone acetate	TABLET;ORAL	220308	ANDA	Eywa Pharma Inc	71930-088	71930-088-13	1000 TABLET in 1 BOTTLE (71930-088-13)

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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