Drug Master Files for: NAFTIFINE HYDROCHLORIDE
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NAFTIFINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 14711 | A | II | 2/15/2000 | ERREGIERRE SPA | NAFTIFINE HYDROCHLORIDE USP |
| 16772 | A | II | 8/19/2003 | NOVARTIS PHARMA AG | NAFTIFINE HYDROCHLORIDE |
| 18147 | A | II | 3/4/2005 | OLON SPA | NAFTIFINE HYDROCHLORIDE |
| 23456 | A | II | 8/3/2010 | SHANGHAI ZIYUAN PHARMACEUTICAL CO LTD | NAFTIFINE HYDROCHLORIDE |
| 24619 | A | II | 6/27/2012 | TARO PHARMACEUTICAL INDUSTRIES LTD | NAFTIFINE HYDROCHLORIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
