Drug Master Files for: protirelin
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protirelin Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10251 | I | II | 5/14/1993 | ABBOTT LABORATORIES | PROTIRELIN (TRH) |
12272 | I | II | 12/6/1996 | AVENTIS PHARMA DEUTSCHLAND GMBH | BULK PROTIRELIN (THYROID RELEASING HORMONE; TRH) DRUG SUBSTANCE |
6434 | I | II | 1/9/1984 | HOFFMANN LA ROCHE INC | PROTIRELIN (THYROTROPIN RELEASING HORMONE) |
7945 | I | II | 3/1/1989 | TANABE SEIYAKU CO LTD | PROTIRELIN |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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