Drug Master Files for: CROTAMITON
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CROTAMITON Drug Master Files
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 |
4413 | I | II | 1/11/1982 | TROPONWERKE GMBH CO KG | CROTAMITON |
5728 | I | II | 3/6/1985 | CHEMISCHE WERKE LAHR 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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