Drug Master Files for: TIZANIDINE HYDROCHLORIDE
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TIZANIDINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15525 | A | II | 7/4/2001 | FARMAK AS | TIZANIDINE HCL |
| 15555 | I | II | 7/30/2001 | FARCHEMIA SRL | TIZANIDINE HYDROCHLORIDE |
| 15699 | A | II | 11/2/2001 | DR REDDYS LABORATORIES LTD | TIZANIDINE HYDROCHLORIDE USP |
| 15727 | A | II | 10/31/2001 | SUN PHARMACEUTICAL INDUSTRIES LTD | TIZANIDINE HYDROCHLORIDE USP |
| 15730 | I | II | 11/14/2001 | HETERO DRUGS LTD | TIZANIDINE HYDROCHLORIDE |
| 15739 | A | II | 11/12/2001 | UNICHEM LABORATORIES LTD | TIZANIDINE HCL USP |
| 15820 | A | II | 1/22/2002 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TIZANIDINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
