Drug Master Files for: irinotecan hydrochloride
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irinotecan hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17312 | A | II | 4/20/2004 | SCINOPHARM TAIWAN LTD | IRINOTECAN HYDROCHLORIDE |
| 17348 | I | II | 5/13/2004 | CHEMWERTH INC | IRINOTECAN HCL (NON-STERILE BULK DRUG SUBSTANCE) |
| 17456 | A | II | 6/8/2004 | CIPLA LTD | IRINOTECAN HYDROCHLORIDE TRIHYDRATE USP |
| 18818 | A | II | 9/23/2005 | FRESENIUS KABI ONCOLOGY LTD | IRINOTECAN HYDROCHLORIDE TRIHYDRATE |
| 18891 | A | II | 10/20/2005 | YAKULT HONSHA CO LTD | TOTAL SYNTHESIS OF TSN-38B-11 INTERMEDIATE COMPOUND USED IN THE MANUFACTURE OF IRINOTECAN HYDROCHLORIDE TRIHYRATE (CPT-11) DRUG SUBSTANCE |
| 18969 | I | II | 10/30/2005 | POLYMED THERAPEUTICS INC | IRINOTECAN HYDROCHLORIDE TRIHYDRATE (NON-STERILE BULK) DRUG SUBSTANCE |
| 19050 | A | II | 12/20/2005 | PLIVA-LACHEMA AS | IRINOTECAN HYDROCHLORIDE TRIHYDRATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
