Drug Master Files for: darunavir
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darunavir Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18825 | A | II | 11/2/2005 | JANSSEN PHARMACEUTICA NV | DARUNAVIR (R319064) DRUG SUBSTANCE |
| 23660 | A | II | 3/16/2011 | CIPLA LTD | DARUNAVIR |
| 23661 | A | II | 7/6/2010 | CIPLA LTD | DARUNAVIR HYDRATE |
| 23662 | A | II | 6/15/2010 | CIPLA LTD | DARUNAVIR ETHANOLATE |
| 23850 | A | II | 2/10/2011 | LUPIN LTD | DARUNAVIR ETHANOLATE |
| 23854 | A | II | 6/2/2010 | HETERO LABS LTD | DARUNAVIR AMORPHOUS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
