Viewing data from:

PREDNICARBATE

ANDA

PREDNICARBATE | A077287 | FOUGERA PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain2 active DMFs2 inactive

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

TAPI NL BVPREDNICARBATE DRUG SUBSTANCE

DMF 170312003

TARO PHARMACEUTICAL INDUSTRIES LTDPREDNICARBATE USP MICRONIZED

DMF 205102007

CHEMAGIS LTDInactivePREDNICARBATE

DMF 164852003

SANOFI AVENTIS DEUTSCHLAND GMBHInactivePREDNICARBATE

DMF 255042011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 20, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Sep 19, 2006

No patent or exclusivity listings for this strength.