Drug Master Files for: Roche
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Roche Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1007 | I | II | 11/1/1966 | HOFFMANN LA ROCHE INC | COMPOSITION & GR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307 |
10092 | I | III | 2/18/1993 | SABIC PETROCHEMICALS BV | SABIC LDPE 2100TN00 |
10093 | I | III | 2/18/1993 | SABIC PETROCHEMICALS BV | SABIC LDPE 2200TC00 |
10094 | I | III | 2/18/1993 | SABIC PETROCHEMICALS BV | SABIC LDPE 2200TC12 |
10141 | I | III | 3/1/1993 | MITSUI PETROCHEMICAL AMERICA LTD | ADMER Q F 500 A |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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