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FLUDROCORTISONE ACETATE

ANDA

FLUDROCORTISONE ACETATE | A040425 | BARR LABORATORIES INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition from Rising Pharma Holdings, Inc. FDA-2024-P-4514 · 10 docket documents Rising Pharma Holdings, Inc. filed this amendment to suitability petition FDA-2024-P-4514 to seek permission to file an ANDA for Fludrocortisone Acetate Tablets in 0.05 mg, 0.1 mg, and 0.2 mg strengths. The amendment provides proposed product labeling (package inserts) in response to the FDA's Octob	Suitability	2024-10-10	Granted	Rising Pharma Holdings, Inc.

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.

Products (1)

#001 — 0.1MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 21, 2003

No patent or exclusivity listings for this strength.