Drug Master Files for: CLOPIDOGREL BISULFATE
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CLOPIDOGREL BISULFATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12439 | I | II | 3/6/1997 | SANOFI AVENTIS CHIMIE | CLOPIDOGREL BISULFATE |
| 12460 | I | II | 4/8/1997 | SANOFI SYNTHELABO INC | CLOPIDOGREL BISULFATE |
| 14809 | A | II | 3/31/2000 | SANOFI CHIMIE | CLOPIDOGREL BISULFATE FORM II |
| 14849 | I | II | 5/4/2000 | CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTD | CLOPIDOGREL BISULFATE FORM I |
| 15458 | I | II | 5/3/2001 | BASF ORGAMOL PHARMA SOLUTIONS SA | CLOPIDOGREL BISULFATE, FORM II |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
