Drug Master Files for: granisetron
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granisetron Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13844 | A | II | 11/19/1998 | WAVELENGTH ENTERPRISES LTD | GRANISETRON HYDROCHLORIDE |
| 16470 | I | II | 3/10/2003 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | GRANISETRON |
| 16560 | A | II | 4/23/2003 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | GRANISETRON HYDROCHLORIDE USP |
| 16838 | A | II | 9/5/2003 | CHONGQING CARELIFE PHARMACEUTICAL CO LTD | GRANISETRON HYDROCHLORIDE USP |
| 17346 | A | II | 4/5/2004 | INKE SA | GRANISETRON HYDROCHLORIDE |
| 17476 | I | II | 6/18/2004 | AMINO CHEMICALS LTD | GRANISETRON HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
