Drug Master Files for: posaconazole
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posaconazole Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 24346 | A | II | 11/5/2010 | SANDOZ PRIVATE LTD | POSACONAZOLE |
| 27614 | A | II | 10/11/2013 | MSN LABORATORIES PRIVATE LTD | POSACONAZOLE AMORPHOUS [ROUTE CODE PKA] |
| 27720 | A | II | 11/22/2013 | MSN LABORATORIES PRIVATE LTD | POSACONAZOLE (FORM-I) [ROUTE CODE - PJ1] |
| 28223 | A | II | 1/5/2017 | ALP PHARM BEIJING CO LTD | POSACONAZOLE FOMR I |
| 28314 | A | II | 6/10/2014 | BRIGHTGENE BIOMEDICAL TECHNOLOGY CO LTD | POSACONAZOLE |
| 28386 | A | II | 6/3/2014 | WUHAN ZY PHARMACEUTICAL CO LTD | POSACONAZOLE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
