Last Updated: November 13, 2026

Drug Master Files for: CROTAMITON

CROTAMITON Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
11393	I	II	3/15/1995	BOEHRINGER INGELHEIM PHARMA KG	CROTAMITON
15285	A	II	2/8/2001	BIDACHEM SPA	CROTAMITON
26374	A	II	8/29/2012	SYN-TECH CHEM AND PHARM CO LTD	CROTAMITON USP
33121	A	II	9/28/2018	MIDAS PHARMA GMBH	CROTAMITON
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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