Drug Master Files for: topotecan hydrochloride
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topotecan hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19834 | I | II | 10/4/2006 | DR REDDYS LABORATORIES LTD | TOPOTECAN HYDROCHLORIDE |
| 20723 | I | II | 6/20/2007 | SAI PHYTOCEUTICALS PVT LTD | TOPOTECAN HYDROCHLORIDE |
| 20810 | A | II | 8/22/2007 | SCINOPHARM TAIWAN LTD | TOPOTECAN HYDROCHLORIDE DRUG SUBSTANCE |
| 21621 | A | II | 7/17/2008 | CIPLA LTD | TOPOTECAN HYDROCHLORIDE |
| 22303 | I | II | 1/6/2009 | FRESENIUS KABI ONCOLOGY LTD | TOPOTECAN HYDROCHLORIDE |
| 22859 | A | II | 6/30/2010 | CHEMWERTH INC | TOPOTECAN HCL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
