Drug Master Files for: baclofen
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baclofen Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12438 | I | II | 3/12/1997 | PFC ITALIANA SRL DIV ALFA CHEMICALS ITALIANA | BACLOFEN |
| 12541 | A | II | 4/17/1997 | FINE CHEMICALS CORP PTY LTD | (R)-(-)-BACLOFEN |
| 18014 | A | II | 1/20/2005 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | BACLOFEN |
| 18220 | A | II | 3/30/2005 | MYLAN LABORATORIES LTD | BACLOFEN USP |
| 20885 | A | II | 9/25/2007 | EXCELLA GMBH AND CO KG | R-BACLOFEN |
| 22881 | A | II | 6/22/2009 | SUMITOMO CHEMICAL CO LTD | R BACLOFEN |
| 28455 | A | II | 7/31/2014 | PIRAMAL ENTERPRISES LTD | BACLOFEN |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
