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FLUDROCORTISONE ACETATE

ANDA

FLUDROCORTISONE ACETATE | A040431 | IMPAX LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Rising Pharma Holdings, Inc FDA-2024-P-4514 Rising Pharma Holdings, Inc. filed a suitability petition under 21 CFR 314.93 requesting FDA approval to submit an Abbreviated New Drug Application for Fludrocortisone Acetate Tablets in 0.05 mg and 0.2 mg strengths, which differ from the reference listed drug Florinef (0.1 mg) and reference standar	Suitability	2024-09-25	Open	Rising Pharma Holdings

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain5 active DMFs1 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

FARMABIOS SPAFLUDROCORTISONE ACETATE

DMF 141361999

TAPI NL BVFLUDROCORTISONE ACETATE

DMF 147031999

CURIA SPAIN SAUFLUDROCORTISONE ACETATE USP

DMF 210542007

NOVITIUM PHARMA LLCFLUDROCORTISONE ACETATE USP

DMF 349232020

HENAN LIHUA PHARMACEUTICAL CO LTDFLUDROCORTISONE ACETATE

DMF 363672021

MYLAN LABORATORIES LTDInactiveFLUDROCORTISONE ACETATE USP

DMF 229942009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 18, 2002

No patent or exclusivity listings for this strength.