Drug Master Files for: Roche Palo
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Roche Palo Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
3240 | I | II | 6/30/1978 | ROCHE PALO ALTO LLC | RS-37619-00-31-3 (RS-37619, TROMETHAMINE SALT) |
3351 | I | II | 10/31/1978 | ROCHE PALO ALTO LLC | BUTOCONAZOLE NITRATE |
8092 | I | II | 6/1/1989 | ROCHE PALO ALTO LLC | TICLOPIDINE HCL- BOULDER, CO, SPRINGFIELD, MO, EVIONNAZ,SWITZ |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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