Drug Master Files for: palbociclib
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palbociclib Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 32273 | A | II | 3/23/2018 | HETERO LABS LTD | PALBOCICLIB |
| 32294 | A | II | 12/21/2017 | MYLAN LABORATORIES LTD | PALBOCICLIB |
| 32646 | A | II | 3/28/2018 | DR REDDYS LABORATORIES LTD | PALBOCICLIB |
| 32867 | A | II | 8/3/2018 | BIOPHORE INDIA PHARMACEUTICALS PVT LTD | PALBOCICLIB |
| 32907 | A | II | 7/25/2018 | APOTEX PHARMACHEM INC | PALBOCICLIB |
| 32925 | A | II | 7/16/2018 | SCINOPHARM TAIWAN LTD | PALBOCICLIB |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
