Drug Master Files for: stavudine
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stavudine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17646 | A | II | 8/31/2004 | CIPLA LTD | STAVUDINE USP |
| 17968 | A | II | 12/30/2004 | AUROBINDO PHARMA LTD | STAVUDINE USP |
| 17976 | I | II | 1/6/2004 | MYLAN LABORATORIES LTD | STAVUDINE USP |
| 17997 | A | II | 1/17/2005 | HETERO LABS LTD | STAVUDINE |
| 19837 | A | II | 9/29/2006 | AUROBINDO PHARMA LTD | STAVUDINE USP (NON-STERILE DRUG SUBSTANCE) |
| 19863 | A | II | 10/3/2006 | ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE | STAVUDINE |
| 20087 | I | II | 12/27/2006 | RANBAXY LABORATORIES LTD | STAVUDINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
