Drug Master Files for: TEMOZOLOMIDE
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TEMOZOLOMIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19347 | A | II | 4/10/2006 | WAVELENGTH ENTERPRISES LTD | TEMOZOLOMIDE |
| 21669 | A | II | 5/25/2008 | JIANGSU TASLY DIYI PHARMACEUTICAL CO LTD | TEMOZOLOMIDE (BULK, NON-STERILE A PHARMACEUTICAL INGREDIENT) |
| 22775 | A | II | 5/12/2009 | RELIANCE LIFE SCIENCES PVT LTD | TEMOZOLOMIDE USP |
| 23158 | A | II | 10/6/2009 | FORMOSA LABORATORIES INC | TEMOZOLOMIDE |
| 23479 | A | II | 1/22/2010 | SHILPA MEDICARE LTD | TEMOZOLOMIDE USP |
| 23547 | A | II | 2/17/2010 | CHEMWERTH INC | TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE) |
| 23553 | A | II | 3/8/2010 | SUN PHARMACEUTICAL INDUSTRIES LTD | TEMOZOLOMIDE USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
