Drug Master Files for: MEMANTINE HYDROCHLORIDE
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MEMANTINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18436 | A | II | 6/17/2005 | UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) | MEMANTINE HYDROCHLORIDE |
| 18562 | A | II | 7/29/2005 | OLON SPA | MEMANTINE HYDROCHLORIDE |
| 19024 | I | II | 12/14/2005 | ESTEVE QUIMICA SA | MEMANTINE HYDROCHLORIDE |
| 19465 | A | II | 5/22/2006 | INDUSTRIALE CHIMICA SRL | MEMANTINE HYDROCHLORIDE USP |
| 19549 | A | II | 6/20/2006 | AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA | MEMANTINE HYDROCHLORIDE |
| 20151 | I | II | 4/2/2007 | TAI HENG INDUSTRY CO LTD | MEMANTINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
