Drug Master Files for: CARVEDILOL PHOSPHATE
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CARVEDILOL PHOSPHATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15865 | A | II | 2/20/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | CARVEDILOL USP |
| 16044 | A | II | 7/8/2002 | MOEHS IBERICA SL | CARVEDILOL |
| 16330 | A | II | 1/29/2003 | DR REDDYS LABORATORIES LTD | CARVEDILOL FORM-2 |
| 16530 | I | II | 4/8/2003 | ZENTIVA AS | CARVEDILOL |
| 17060 | A | II | 12/18/2003 | ZAKLADY FARMACEUTYCZNE POLPHARMA SA | CARVEDILOL |
| 17187 | A | II | 2/25/2004 | CIPLA LTD | CARVEDILOL USP |
| 17405 | I | II | 5/17/2004 | ZACH SYSTEM SPA | CARVEDILOL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
