Drug Master Files for: EPINEPHRINE
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EPINEPHRINE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12037 | A | II | 7/10/1996 | CAMBREX PROFARMACO MILANO SRL | NOREPINEPHRINE BITARTRATE OR NORADRENALINE ACID TARTRATE |
| 15367 | I | II | 3/30/2001 | WUHAN WUYAO PHARMACEUTICAL CO LTD | NOREPINEPHRINE BITARTRATE USP, NON-STERILE, BULK DRUG |
| 16344 | A | II | 12/20/2002 | CHEMPACIFIC CORP | NOREPINEPHRINE BITARTRATE |
| 21213 | A | II | 12/31/2007 | WOCKHARDT LTD | Epinephrine USP |
| 21716 | A | II | 6/6/2008 | AMRI RENSSELAER INC | RACEPINEPHRINE HYDROCHLORIDE, USP DRUG SUBSTANCE |
| 25874 | A | II | 3/12/2012 | DERIVADOS QUIMICOS SAU | RACEPINEPHRINE HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
