Drug Master Files for: HYDROGEN PEROXIDE
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HYDROGEN PEROXIDE Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1000 | I | 9/15/1966 | GENERAL FOODS CORP | MONSODIUM DIHYDROGEN PHOSPHATE | |
10676 | I | II | 12/15/1993 | CHEMICAL PHARMACEUTICAL RESEARCH INSTITUTE NIHFI LTD | KETOTIFEN HYDROGEN |
11214 | A | IV | 11/30/1994 | STEPAN SPECIALTY PRODUCTS LLC | WECOBEE? S, HYDROGENATED VEGETABLE OIL |
11227 | I | II | 12/1/1994 | MALLINCKRODT CHEMICAL INC | SODIUM HYDROGEN L-TARTRATE |
12475 | A | II | 4/17/1997 | RANKE QUIMICA SA | ALMOTRIPTAN, LAS 31416 D,L HYDROGEN MALATE |
15577 | I | II | 8/3/2001 | ERREDUE SPA INNOVATIVE CHEMICAL AND LIFE | TIAMULIN HYDROGEN FUMARATE CLARIANT |
15650 | I | II | 9/25/2001 | FMC CORP HYDROGEN PEROXIDE DIV | HYDROGEN PEROXIDE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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