Drug Master Files for: carboplatin
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carboplatin Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 12369 | I | II | 2/21/1997 | DEGUSSA AG WERK RADEBEUL | CARBOPLATIN, USP |
| 15147 | A | II | 11/17/2000 | HERAEUS DEUTSCHLAND GMBH AND CO KG | CARBOPLATIN USP |
| 15938 | A | II | 4/18/2002 | STREM CHEMICALS INC | CARBOPLATIN (USP) |
| 16280 | I | II | 12/2/2002 | PLIVA-LACHEMA AS | CARBOPLATIN |
| 16664 | A | II | 6/20/2003 | SUN PHARMACEUTICAL INDUSTRIES LTD | CARBOPLATIN USP |
| 16709 | I | II | 7/15/2003 | INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD | CARBOPLATIN |
| 16916 | A | II | 10/21/2003 | CIPLA LTD | CARBOPLATIN 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
