Drug Master Files for: ABACAVIR SULFATE
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ABACAVIR SULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18229 | A | II | 3/30/2005 | MYLAN LABORATORIES LTD | ABACAVIR SULFATE USP |
| 18256 | A | II | 3/24/2005 | AUROBINDO PHARMA LTD | ABACAVIR SULFATE USP |
| 20515 | A | II | 5/8/2007 | OLON USA INC | ABACAVIR SULFATE |
| 22196 | A | II | 11/17/2008 | HETERO LABS LTD | ABACAVIR SULFATE |
| 23618 | A | II | 4/8/2010 | LUPIN LTD | ABACAVIR SULFATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
