Drug Master Files for: AMANTADINE HYDROCHLORIDE
✉ Email this page to a colleague
AMANTADINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 23528 | A | II | 2/11/2010 | OLAINFARM JSC | AMANTADINE HYDROCHLORIDE |
| 25151 | A | II | 7/21/2011 | ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO LTD | AMANTADINE HYDROCHLORIDE USP |
| 2817 | I | II | 1/7/1977 | CILAG CHEMIE AG | AMANTADINE HCL |
| 29486 | A | II | 9/1/2015 | ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPA | AMANTADINE HYDROCHLORIDE |
| 3739 | I | II | 2/21/1980 | CHEMOSWED AB | 1-AMINOADAMANTANE HCL (AMANTADINE HCL) |
| 6924 | A | II | 4/8/1987 | MOEHS IBERICA SL | AMANTADINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
