Drug Master Files for: CLORAZEPATE DIPOTASSIUM
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CLORAZEPATE DIPOTASSIUM Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14169 | A | II | 6/2/1999 | TARO PHARMACEUTICAL INDUSTRIES LTD | CLORAZEPATE DIPOTASSIUM USP |
| 16980 | I | II | 11/25/2003 | SUN PHARMACEUTICAL INDUSTRIES LTD | CLORAZEPATE DIPOTASSIUM USP |
| 3978 | I | II | 11/4/1980 | INDUSTRIA CHIMICA PROFARMACO SPA | CLORAZEPATE DIPOTASSIUM, BULK FORM |
| 4240 | A | II | 6/26/1981 | CAMBREX PROFARMACO MILANO SRL | CLORAZEPATE DIPOTASSIUM |
| 4257 | I | II | 8/10/1981 | SANOFI SA | CLORAZEPATE DIPOTASSIUM |
| 4535 | I | II | 5/7/1982 | ABBVIE INC | CLORAZEPATE DIPOTASSIUM (TRANXENE) |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
