Drug Master Files for: dobutamine hydrochloride
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dobutamine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 10097 | I | II | 2/11/1993 | EGIS PHARMACEUTICALS PRIVATE LTD | DOBUTAMINE HYDROCHLORIDE |
| 10296 | I | II | 6/14/1993 | CHEMSYN SCIENCE LABORATORIES | DOBUTAMINE HYDROCHLORIDE |
| 10706 | I | II | 1/28/1994 | IROTEC LABORATORIES | DOBUTAMINE HYDROCHLORIDE |
| 11023 | A | II | 8/2/1994 | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH | DOBUTAMINE HYDROCHLORIDE |
| 11083 | I | II | 9/15/1994 | SOCHINAZ SA | DOBUTAMINE HCL |
| 12528 | I | II | 5/30/1997 | HOECHST MARION ROUSSEL SA | DOBUTAMINE ISONICOTINATE/ OFF-0358-A-01-1 |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
