Drug Master Files for: capecitabine
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capecitabine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21620 | A | II | 8/19/2009 | CIPLA LTD | CAPECITABINE USP |
| 22014 | I | II | 8/28/2008 | JIANGSU ZW PHARMACEUTICALS CO LTD | CAPECITABINE |
| 22140 | A | II | 10/27/2008 | HETERO LABS LTD | CAPECITABINE, USP |
| 22157 | A | II | 10/27/2008 | DIVI'S LABOTATORIES LTD | CAPECITABINE |
| 22479 | A | II | 1/30/2009 | DR REDDYS LABORATORIES LTD | CAPECITABINE USP |
| 22954 | A | II | 7/17/2009 | AARTI INDUSTRIES LTD | CAPECITABINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
