Drug Master Files for: butorphanol tartrate
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butorphanol tartrate Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10385 | A | II | 8/2/1993 | TEVA PHARMACEUTICAL INDUSTRIES LTD | BUTORPHANOL TARTRATE |
| 12119 | I | II | 9/3/1996 | TASMANIAN ALKALOIDS PARTY LTD | BUTORPHANOL TARTRATE |
| 12921 | I | II | 3/27/1998 | ABBOTT LABORATORIES LTD | BUTORPHANOL TARTRATE USP |
| 14842 | A | II | 4/20/2000 | CEDARBURG PHARMACEUTICALS INC | BUTORPHANOL TARTRATE, USP |
| 25670 | A | II | 1/17/2012 | SRI KRISHNA PHARMACEUTICALS LTD | BUTORPHANOL TARTRATE USP |
| 31875 | A | II | 6/29/2017 | HIKAL LTD | BUTORPHANOL TARTRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
