Drug Master Files for: levorphanol tartrate
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levorphanol tartrate Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
18823 | A | II | 9/29/2005 | SPECGX LLC | LEVORPHANOL TARTRATE USP SPECIAL |
20747 | A | II | 8/2/2007 | SPECGX LLC | LEVORPHANOL BASE |
33224 | A | II | 12/31/2018 | NOVITIUM PHARMA LLC | LEVORPHANOL TARTRATE USP |
3726 | I | II | 2/15/1980 | HOFFMANN LA ROCHE INC | LEVORPHANOL TARTRATE AMPULES, 5ML,0.25MG/ML MNFG.IN NEW JERSEY FACIL. |
7625 | I | II | 8/9/1988 | MALLINCKRODT PHARMS DIV MALLINCKRODT INC | LEVORPHANOL TARTRATE |
9968 | I | II | 11/13/1992 | MALLINCKRODT INC | LEVORPHANOL 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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