Drug Master Files for: GEMCITABINE HYDROCHLORIDE
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GEMCITABINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18810 | A | II | 9/24/2005 | JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | GEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) |
| 18857 | A | II | 10/11/2005 | DR REDDYS LABORATORIES LTD | GEMCITABINE HYDROCHLORIDE USP |
| 19053 | A | II | 12/19/2005 | SCINOPHARM TAIWAN LTD | GEMCITABINE HYDROCHLORIDE USP |
| 19427 | A | II | 5/16/2006 | SUN PHARMACEUTICAL INDUSTRIES LTD | GEMCITABINE HYDROCHLORIDE USP |
| 20979 | A | II | 10/29/2007 | TEVA PHARMACEUTICAL INDUSTRIES LTD | GEMCITABINE HYDROCHLORIDE |
| 21274 | I | II | 1/22/2008 | BENZOCHEM LIFESCIENCES PVT LTD | GEMCITABINE HYDROCHLORIDE USP |
| 21399 | A | II | 4/22/2008 | FRESENIUS KABI ONCOLOGY LTD | GEMCITABINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
