Drug Master Files for: TICLOPIDINE HYDROCHLORIDE
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TICLOPIDINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10492 | A | II | 9/15/1993 | SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL | TICLOPIDINE HYDROCHLORIDE |
| 11664 | A | II | 9/21/1995 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TICLOPIDINE HCL |
| 11968 | A | II | 5/17/1996 | ERREGIERRE SPA | TICLOPIDINE HYDROCHLORIDE |
| 12643 | A | II | 9/4/1997 | EUTICALS SPA | TICLOPIDINE HYDROCHLORIDE |
| 22355 | I | II | 12/30/2008 | AARTI DRUGS LTD | TICLOPIDINE HYDROCHLORIDE |
| 3599 | I | II | 8/22/1979 | ORGAMOL SA | TICLOPIDINE |
| 7975 | I | II | 1/17/1989 | SANOFI SYNTHELABO INC | TICLOPIDINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
