Drug Master Files for: Alza
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Alza Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10005 | I | II | 12/15/1992 | ALZA CORP | GITS (VENLAFAXINE HYDROCHLORIDE) |
2037 | I | I | 1/5/1973 | ALZA CORP | MANUFACTURE FACILITIES AND CONTROLS |
3010 | I | IV | 7/29/1977 | ALZA CORP | ALZAMER CELLULOSIC RATE CONTROLLING MEMBRANE PRECURSORS |
3168 | I | II | 2/28/1978 | ALZA CORP | FACILITIES OF ALZA MEXICANA S.A. -ESTADO de MEXICO |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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