Drug Master Files for: MELPHALAN HYDROCHLORIDE
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MELPHALAN HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20073 | A | II | 12/20/2006 | CHEMPACIFIC CORP | MELPHALAN DRUG SUBSTANCE |
| 20883 | A | II | 9/24/2007 | OLON SPA | MELPHALAN HYDROCHLORIDE |
| 23667 | I | II | 4/1/2010 | XIAN LIBANG PHARMACEUTICAL CO LTD | MELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE) |
| 25040 | A | II | 7/1/2011 | EMCURE PHARMACEUTICALS LTD | MELPHALAN HYDROCHLORIDE |
| 25644 | A | II | 12/29/2011 | CHEMWERTH INC | MELPHALAN HCL, NON-STERILE, BULK DRUG SUBSTANCE |
| 25791 | A | II | 2/14/2012 | FARMABIOS SPA | MELPHALAN HYDROCHLORIDE |
| 27306 | A | II | 7/10/2013 | NERPHARMA SRL | MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
