Drug Master Files for: TAKEDA
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TAKEDA Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10225 | I | II | 4/30/1993 | TAKEDA CHEMICAL INDUSTRIES LTD | TAK-536 DRUG SUBSTANCE |
10263 | I | II | 5/27/1993 | TAKEDA CHEMICAL INDUSTRIES LTD | TAP-144-SR(N) 7.5 AND 3.75 MG. |
10416 | A | II | 8/13/1993 | TAKEDA PHARMACEUTICAL CO LTD | LEUPROLIDE ACETATE |
10418 | I | II | 8/13/1993 | TAKEDA CHEMICAL INDUSTRIES LTD | FACILITIES AND OPERATING PROCEDURES IN HIKARI-CITY, YAMAGUCHI, JAPAN |
11395 | A | II | 3/24/1995 | TAKEDA PHARMACEUTICAL CO LTD | TAP-144-SR (1M) |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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