Drug Master Files for: terbinafine
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terbinafine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15887 | A | II | 3/6/2002 | DR REDDYS LABORATORIES LTD | TERBINAFINE HYDROCHLORIDE USP |
| 16187 | A | II | 10/4/2002 | UQUIFA MEXICO SA DE CV | TERBINAFINE HYDROCHLORIDE |
| 16283 | A | II | 11/28/2002 | AMINO CHEMICALS LTD | TERBINAFINE HYDROCHLORIDE |
| 16511 | A | II | 3/26/2003 | GEDEON RICHTER PLC | TERBINAFINE HYDROCHLORIDE USP |
| 16784 | I | II | 8/20/2003 | PERRIGO API LTD | TERBINAFINE HYDROCHLORIDE |
| 17291 | I | II | 3/19/2004 | RECORDATI ESPANA SL | TERBINAFINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
