Drug Master Files for: iron
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iron Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10075 | I | II | 2/5/1993 | PHARMACHEM CORP | IRON DEXTRAN |
10414 | I | II | 8/9/1993 | ARCHIMICA SPA | BUSPIRONE HYDROCHLORIDE |
10624 | I | IV | 12/17/1993 | WARNER JENKINSON CO | NO. 62060 SYNTHETIC RED IRON OXIDE, NO. 82150 SYNTHETIC BLACK IRON OXIDE AND NO. 35070 SYNTHETIC YELLOW IRON OXIDE |
1094 | I | II | 10/27/1967 | CHEMDEX INC | IRON HY-DEX HUMAN USE |
11148 | A | II | 10/21/1994 | FERMION OY | BUSPIRONE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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