Drug Master Files for: tolterodine tartrate
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tolterodine tartrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 16995 | A | II | 12/3/2003 | TEVA PHARMACEUTICAL INDUSTRIES LTD | TOLTERODINE TARTRATE |
| 17018 | A | II | 12/11/2003 | CIPLA LTD | TOLTERODINE TARTRATE USP |
| 17026 | I | II | 12/15/2003 | SUN PHARMACEUTICAL INDUSTRIES LTD | TOLTERODINE TARTRATE |
| 17736 | A | II | 10/6/2004 | DR REDDYS LABORATORIES LTD | TOLTERODINE TARTRATE |
| 18030 | I | II | 1/24/2005 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | TOLTERODINE TARTRATE, NON-STERILE A PHARMACEUTICAL INGREDIENT |
| 19324 | A | II | 3/31/2006 | LUPIN LTD | TOLTERODINE TARTRATE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
