Viewing data from:

CICLOPIROX

ANDA

CICLOPIROX | A078233 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

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
Sep 25, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Sep 18, 2007

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals, Inc. updated its corporate name to Cosette Pharms NC for ciclopirox (ciclopirox) NDA 078233.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated the registered applicant name for Ciclopirox (NDA 078233) from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC