Drug Master Files for: NILOTINIB HYDROCHLORIDE
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NILOTINIB HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 25338 | I | II | 9/28/2011 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | NILOTINIB HYDROCHLORIDE MONOHYDRATE (FORM B) (VERSION NO.: 1) |
| 25412 | I | II | 10/19/2011 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | NILOTINIB HYDROCHLORIDE MONOHYDRATE (VERSION NO.: 1) |
| 26497 | I | II | 9/28/2012 | SICHUAN XIELI PHARMACEUTICAL CO LTD | NILOTINIB |
| 28102 | A | II | 7/15/2014 | TEVA PHARMACEUTICAL INDUSTRIES LTD | NILOTINIB HYDROCHLORIDE |
| 30088 | A | II | 12/31/2015 | DR REDDYS LABORATORIES LTD | NILOTINIB HYDROCHLORIDE |
| 30098 | A | II | 12/9/2015 | HETERO LABS LTD | NILOTINIB HYDROCHLORIDE DIHYDRATE |
| 30164 | A | II | 12/29/2015 | HIKMA PHARMACEUTICALS PLC | NILOTINIB MONOHYDROCHLORIDE ANHYDROUS |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
