Drug Master Files for: TROMETHAMINE
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TROMETHAMINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10372 | I | II | 11/2/1993 | SYNCHEM CHEMICALS PRIVATE LTD | KETOROLAC TROMETHAMINE |
| 10599 | I | II | 11/29/1993 | ANGUS CHEMICAL CO | TROMETHAMINE (TRIS AMINO) |
| 10740 | I | II | 2/23/1994 | DELMAR CHEMICALS INC | KETOROLAC TROMETHAMINE |
| 11507 | I | II | 5/15/1995 | MAPRIMED SA | KETOROLAC TROMETHAMINE |
| 11736 | I | II | 11/3/1995 | ABBOTT LABORATORIES CHEMICAL AND AGRICULTURAL PRODUCTS DIV | KETOROLAC TROMETHAMINE |
| 11799 | I | II | 1/4/1996 | CILAG AG | KETOROLAC TROMETHAMINE |
| 11980 | A | II | 5/24/1996 | QUIMICA SINTETICA SA | KETOROLAC TROMETHAMINE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
