Drug Master Files for: Idt
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Idt Drug Master Files
DMF No. | Status | Type | Submission Date | Holder | Subject |
---|---|---|---|---|---|
10973 | I | IV | 7/8/1994 | GOLDSCHMIDT CHEMICAL DIV WILSON PHARMA AND CHEMICAL CORP | PEG-25 GLYCERYL TRIOLEATE, (TAGAT TO) |
12328 | A | II | 1/20/1997 | IDT AUSTRALIA LTD | MITOXANTRONE HYDROCHLORIDE USP |
12997 | A | II | 5/21/1998 | IDT AUSTRALIA LTD | ACETAZOLAMIDE USP |
14170 | A | II | 6/1/1999 | IDT AUSTRALIA LTD | THIOTEPA USP |
14839 | A | II | 4/24/2000 | IDT AUSTRALIA LTD | HEMATOPORPHYRIN DIACETATE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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