Drug Master Files for: ERLOTINIB HYDROCHLORIDE
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ERLOTINIB HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21786 | A | II | 7/11/2008 | NATCO PHARMA LTD | ERLOTINIB HYDROCHLORIDE |
| 23136 | I | II | 7/27/2009 | TAI HENG INDUSTRY CO LTD | ERLOTINIB HYDROCHLORIDE |
| 23183 | A | II | 10/16/2009 | TEVA PHARMACEUTICAL INDUSTRIES LTD | ERLOTINIB HCL |
| 23345 | I | II | 11/30/2009 | ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTD | ERLOTINIB HYDROCHLORIDE |
| 24499 | A | II | 12/28/2010 | MYLAN LABORATORIES LTD | ERLOTINIB HYDROCHLORIDE |
| 24669 | I | II | 2/25/2011 | MYLAN LABORATORIES LTD | ERLOTINIB HYDROCHLORIDE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
