Drug Master Files for: COPPER
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COPPER Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 11177 | I | II | 10/31/1994 | ARENOL CHEMICAL CORP | COPPER GLYCINATE MONOHYDRATE |
| 12814 | I | II | 1/6/1998 | ZHEJIANG HISUN PHARMACEUTICAL CO LTD | BLEOMYCIN A2 AND B2/COPPER COMPLEX, NON-STERILE BULK DRUG SUBSTANCE |
| 19485 | A | II | 5/31/2006 | NUVIEW LIFE SCIENCES INC | COPPER CHLORIDE (CU-64) RADIOCHEMICAL |
| 19791 | I | II | 9/21/2006 | NUVIEW LIFE SCIENCES INC | COPPER CHLORIDE CU-67 RADIOCHEMICAL |
| 20079 | A | II | 12/22/2006 | CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES | TETRAKIS (2-METHOXYISOBUTYLISONITRILE) COPPER (I) TETRAFLUOROBORATE DRUG SUBSTANCE |
| 2526 | I | II | 8/3/1975 | EI DUPONT DE NEMOURS AND CO INC | COPPER-64 (NITRATE & CHLORIDE) |
| 27149 | I | II | 12/14/1988 | BACHEM AG | (H-GLY-HIS-LYS-OH) 2 COPPER CHELATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
