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HYDROCORTISONE ACETATE

ANDA

HYDROCORTISONE ACETATE | A040259 | IMPERIUM PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs6 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCHYDROCORTISONE ACETATE USP, MICRO & NON-MICRO

DMF 54981984

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 296852015

SYMBIOTEC PHARMALAB LTDHYDROCORTISONE ACETATE USP

DMF 308202016

JIANGSU LIANHUAN PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 361202021

SHANDONG XINHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 376532022

PASADENA RESEARCH LABORATORIES INCInactiveHYDROCORTISONE ACETATE

DMF 1171953

SANOFI CHIMIEInactiveHYDROCORTISONE ACETATE

DMF 35701979

SCHERING AGInactiveHYDROCORTISONE ACETATE

DMF 47451982

QUATRUMInactiveHYDROCORTISONE ACETATE

DMF 67861987

SHANDONG XINHUA PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE ACETATE

DMF 172632004

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE ACETATE

DMF 321352017

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 29, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Jul 29, 1999

No patent or exclusivity listings for this strength.