Drug Master Files for: penicillamine
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penicillamine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13601 | I | II | 9/1/1998 | BIOCHEMIE DEUTSCHLAND GMBH | PENICILLAMINE |
| 19099 | I | II | 1/10/2006 | EVONIK TECHNOCHEMIE GMBH | D-PENICILLAMINE |
| 23156 | I | II | 9/25/2009 | ALP PHARM BEIJING CO LTD | D-PENICILLAMINE USP |
| 24013 | A | II | 7/30/2010 | ATON PHARMA A DIVISION OF VALEANT PHARMACEUTICALS NORTH AMERICA LLC | PENICILLAMINE |
| 24701 | I | II | 3/1/2011 | WANBURY LTD | PENICILLAMINE |
| 26681 | A | II | 11/15/2012 | LABORCHEMIE APOLDA GMBH | D-PENICILLAMINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
