Drug Master Files for: metronidazole
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metronidazole Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
16263 | A | II | 11/18/2002 | UNICHEM LABORATORIES LTD | METRONIDAZOLE USP |
16380 | I | II | 1/16/2003 | TIANJIN ZHONGAN PHARMACEUTICAL CO LTD | METRONIDAZOLE |
19442 | I | II | 3/10/2006 | HEC PHARM CO | METRONIDAZOLE USP, NON-STERILE BULK FORM |
2186 | I | II | 11/15/1973 | COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL | METRONIDAZOLE |
23421 | I | II | 12/30/2009 | WUHAN WUYAO PHARMACEUTICAL CO LTD | METRONIDAZOLE |
26658 | I | II | 11/15/2012 | HUBEI HONGYUAN PHARMACEUTICAL CO LTD | METRONIDAZOLE |
3609 | A | II | 9/3/1979 | CORDEN PHARMA BERGAMO SPA | METRONIDAZOLE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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