Drug Master Files for: Shionogi
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Shionogi Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
1594 | I | IV | 8/13/1970 | SHIONOGI QUALICAPS INC | EMPTY GELATIN CAPSULES |
1994 | I | II | 9/18/1972 | SHIONOGI AND CO LTD | 2A,3A-EPITHIO-5A-ANDROSTAN-17B-OL (10275-S) EPITIOSTANOL |
2899 | I | II | 4/11/1977 | SHIONOGI AND CO LTD | SULFAMETHOXAZOLE N.F. |
3118 | I | II | 11/17/1977 | SHIONOGI AND CO LTD | KEFLEX R SUSTAINED RELEASE CAPSULES (CEPHALEXIN MONOHYDRATE LILLY) |
3395 | I | II | 11/1/1978 | SHIONOGI AND CO LTD | COMPOUND NUMBER 6059-S |
3934 | I | II | 9/9/1980 | SHIONOGI AND CO LTD | COMPOUND # 450088-S |
4661 | I | II | 9/30/1982 | SHIONOGI AND CO LTD | CERULETIDE DIETHYLAMINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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