Drug Master Files for: Ben Venue
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Ben Venue Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
18604 | I | II | 12/12/1989 | BEN VENUE LABORATORIES INC | PEG-L-ASPARAGINASE |
2315 | A | V | 7/26/1974 | BEN VENUE LABORATORIES INC | STERILE PROCESSING FACILITY IN BEDFORD, OHIO |
5541 | I | II | 9/27/1984 | BEN VENUE LABORATORIES INC | CYCLOPHOSPHAMIDE LYOPHILIZED FOR INJ(5 DOSAGE FORMS)BEDFORD,OHIO FAC |
6122 | I | II | 12/12/1985 | BEN VENUE LABORATORIES INC | METHOTREXATE SODIUM FOR INJECTION, LYOPHILIZED |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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