Drug Master Files for: tigecycline
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tigecycline Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 22247 | A | II | 11/29/2008 | UNIMARK REMEDIES LTD | TIGECYCLINE TECHNICAL |
| 22767 | A | II | 5/11/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TIGECYCLINE |
| 22841 | A | II | 6/9/2009 | SANDOZ PRIVATE LTD | TIGECYCLINE HYDROCHLORIDE |
| 25935 | A | II | 5/19/2012 | GLAND PHARMA LTD | TIGECYCLINE USP |
| 26311 | A | II | 9/4/2012 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | TIGECYCLINE USP |
| 26551 | A | II | 9/18/2012 | MELODY HEALTHCARE PVT LTD | TIGECYCLINE USP |
| 27477 | A | II | 8/19/2013 | CHONGQING FUAN PHARMACEUTICAL GROUP CO LTD | TIGECYCLINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
