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CICLOPIROX

ANDA

CICLOPIROX | A076435 | FOUGERA PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: LOPROX(TE code: AB)

API Supply Chain7 active DMFs4 inactive

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

OLON SPACICLOPIROX OLAMINE

DMF 113891995

ERREGIERRE SPACICLOPIROX OLAMINE USP-PH.EUR.

DMF 163522003

ERREGIERRE SPACICLOPIROX USP-EP

DMF 163532002

PCASCICLOPIROX

DMF 170072003

OLON SPACICLOPIROX

DMF 171562004

INTERQUIM SACICLOPIROX USP

DMF 189292005

KUMAR ORGANIC PRODUCTS LIMITEDCICLOPIROX OLAMINE

DMF 423042025

EUROAPI GERMANY GMBHInactiveCICLOPIROX

DMF 146271999

SANOFI AVENTIS DEUTSCHLAND GMBHInactiveCICLOPIROX OLAMINE

DMF 146331999

PIERRE FABRE MEDICAMENTInactiveCICLOPIROX

DMF 171992004

SYNKEM SASInactiveCICLOPIROX

DMF 173472004

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 11, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.77%

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 29, 2004

No patent or exclusivity listings for this strength.