Drug Master Files for: DOPAMINE HYDROCHLORIDE
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DOPAMINE HYDROCHLORIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1063 | I | II | 5/29/1967 | CALBIOCHEM BEHRING CORP | DOPAMINE HCL |
1808 | I | II | 8/24/1971 | REGIS CHEMICAL CO | 6-HYDROXYDOPAMINE (6-OHDA) |
2453 | I | II | 5/23/1975 | WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC | DOPAMINE HYDROCHLORIDE |
3060 | I | II | 11/22/1977 | KYOWA HAKKO KOGYO CO LTD | L-DOPAMINE HYDROCHLORIDE (3-HYDROXYTYRAMINE HYDROCHLORIDE ) |
3116 | A | II | 12/27/1977 | SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBH | DOPAMINE HYDROCHLORIDE |
4415 | I | II | 1/20/1982 | HOECHST CELANESE CORP | DOPAMINE HCL, BULK DRUG SUBSTANCE |
5134 | A | II | 6/10/1983 | RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA | DOPAMINE HCl |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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