Drug Master Files for: CLOZAPINE
✉ Email this page to a colleague
CLOZAPINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10534 | A | II | 10/21/1993 | MEDICHEM SA | CLOZAPINE |
| 10862 | A | II | 4/5/1994 | AREVIPHARMA GMBH | CLOZAPINE |
| 11098 | I | II | 9/26/1994 | SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENT | CLOZAPINE |
| 11195 | A | II | 11/16/1994 | SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTD | CLOZAPINE |
| 11692 | A | II | 10/3/1995 | CAMBREX PROFARMACO MILANO SRL | CLOZAPINE |
| 12014 | I | V | 6/24/1996 | PPD WARS DIV PPD CRV INC | METHODS WARS-P317.01 DETERMINATION OF CLOZAPINE AND NORMETHYLCLOZAPINE IN HUMAN PLASMA BY GAS LIQUID CHROMATOGRAPHY |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
