Drug Master Files for: LAPATINIB DITOSYLATE
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LAPATINIB DITOSYLATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 24788 | A | II | 3/18/2011 | FORMOSA LABORATORIES INC | LAPATINIB DITOSYLATE |
| 26465 | I | II | 9/20/2012 | SICHUAN XIELI PHARMACEUTICAL CO LTD | LAPATINIB TOSYLATE |
| 27602 | A | II | 10/1/2013 | HETERO LABS LTD | LAPATINIB DITOSYLATE MONOHYDRATE |
| 29712 | A | II | 9/10/2015 | ALP PHARM BEIJING CO LTD | LAPATINIB DITOSYLATE |
| 29808 | A | II | 9/15/2015 | CAMBREX CHARLES CITY INC | LAPATINIB DITOSYLATE MONOHYDRATE |
| 30043 | A | II | 12/4/2015 | SCINOPHARM TAIWAN LTD | LAPATINIB DITOSYLATE |
| 32266 | A | II | 1/17/2018 | DELMAR CHEMICALS INC | LAPATINIB DITOSYLATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
