Drug Master Files for: pregabalin
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pregabalin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22111 | A | II | 10/23/2008 | MSN PHARMACHEM PRIVATE LTD | PREGABALIN USP [ROUTE CODE - PB] |
| 22128 | A | II | 11/27/2008 | SUN PHARMACEUTICAL INDUSTRIES LTD | PREGABALIN |
| 22165 | A | II | 11/10/2008 | MYLAN LABORATORIES LTD | (S)-PREGABALIN |
| 22223 | A | II | 11/24/2008 | CHANGZHOU PHARMACEUTICAL FACTORY | PREGABALIN |
| 22242 | A | II | 12/1/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PREGABALIN DRUG SUBSTANCE |
| 22330 | A | II | 12/17/2008 | LUPIN LTD | PREGABALIN |
| 22485 | A | II | 2/3/2009 | MYLAN LABORATORIES LTD | PREGABALIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
