Drug Master Files for: midazolam
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midazolam Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
12553 | A | II | 6/18/1997 | WAVELENGTH ENTERPRISES LTD | MIDAZOLAM |
12686 | A | II | 10/6/1997 | CAMBREX PROFARMACO MILANO SRL | MIDAZOLAM |
12745 | I | II | 11/14/1997 | ABBOTT LABORATORIES HOSP PRODUCTS DIV | MIDAZOLAM |
12910 | I | II | 3/23/1998 | DIOSYNTH BV | MIDAZOLAM |
12929 | I | II | 3/30/1998 | PCAS | MIDAZOLAM BASE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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