Drug Master Files for: THIOTEPA
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THIOTEPA Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13911 | A | II | 12/24/1998 | HERAEUS DEUTSCHLAND GMBH AND CO KG | THIOTEPA USP |
| 14170 | A | II | 6/1/1999 | IDT AUSTRALIA LTD | THIOTEPA USP |
| 14316 | I | II | 7/29/1999 | JIANGSU HENGRUI MEDICINE CO LTD | THIOTEPA USP NON STERILE BULK DRUG |
| 14512 | I | II | 10/26/1999 | TEVA PHARMACEUTICAL INDUSTRIES LTD | THIOTEPA |
| 26383 | A | II | 9/5/2012 | MYLAN LABORATORIES LTD | THIOTEPA USP |
| 30424 | A | II | 3/31/2016 | MSN LABORATORIES PRIVATE LTD | THIOTEPA USP [ROUTE CODE ZT] |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
