Drug Master Files for: palonosetron hydrochloride
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palonosetron hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16063 | A | II | 7/19/2002 | HELSINN ADVANCED SYNTHESIS SA | PALONOSETRON HYDROCHLORIDE USP |
| 18187 | A | II | 3/17/2005 | CATALENT PHARMA SOLUTIONS LLC | PALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS |
| 21123 | A | II | 12/11/2007 | NEULAND LABORATORIES LTD | PALONOSETRON HYDROCHLORIDE |
| 21749 | A | II | 7/1/2008 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PALONOSETRON HCL |
| 23209 | A | II | 10/12/2009 | ALP PHARM BEIJING CO LTD | PALONOSETRON HYDROCHLORIDE |
| 23332 | A | II | 12/3/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | PALONOSETRON 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
