Viewing data from:

HYDROCORTISONE BUTYRATE

ANDA

HYDROCORTISONE BUTYRATE | A209556 | THE J MOLNER CO OU

1 strength0 unique patents0 unique exclusivities

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE BUTYRATE USP

DMF 315442017

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveHYDROCORTISONE BUTYRATE

DMF 104471993

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 18, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Nov 21, 2017

No patent or exclusivity listings for this strength.