Drug Master Files for: argatroban
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argatroban Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20709 | A | II | 7/20/2007 | CHEMWERTH INC | ARGATROBAN HYDRATE (NON-STERILE BULK) DRUG SUBSTANCE |
| 20760 | A | II | 8/7/2007 | EUTICALS SPA | ARGATROBAN |
| 21304 | A | II | 1/30/2008 | LUNDBECK PHARMACEUTICALS ITALY SPA | ARGATROBAN |
| 22855 | A | II | 8/14/2009 | CHEMWERTH INC | INTERMEDIATE 6 OF ARGATROBAN (ARGA 6) |
| 22935 | I | II | 7/10/2009 | SCINOPHARM TAIWAN LTD | ARGATROBAN |
| 25400 | A | II | 10/27/2011 | GLAND PHARMA LTD | ARGATROBAN MONOHYDRATE USP |
| 25765 | A | II | 3/19/2012 | EMCURE PHARMACEUTICALS LTD | ARGATROBAN USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
