Drug Master Files for: zolpidem tartrate
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zolpidem tartrate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10652 | I | II | 1/10/1994 | GADOR SA | ZOLPIDEM HEMITARTRATE |
11764 | A | II | 12/5/1995 | FINORGA SAS | ZOLPIDEM TARTRATE MODIFIED SYNTHESIS |
15131 | A | II | 11/8/2000 | UQUIFA MEXICO SA DE CV | ZOLPIDEM TARTRATE |
15486 | A | II | 6/21/2001 | FARMAK AS | ZOLPIDEM TARTRATE |
15840 | I | II | 1/31/2002 | QUIMICA SINTETICA SA | ZOLPIDEM TARTRATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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