Drug Master Files for: olanzapine
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olanzapine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15052 | A | II | 9/18/2000 | CIPLA LTD | OLANZAPINE |
| 15299 | A | II | 2/23/2001 | DR REDDYS LABORATORIES LTD | OLANZAPINE (FORM 1), USP |
| 18108 | I | II | 2/7/2005 | VENKAT PHARMA LTD | OLANZAPINE |
| 18260 | A | II | 4/8/2005 | SOLARA A PHARMA SCIENCES LTD | OLANZAPINE USP |
| 18867 | A | II | 10/14/2005 | MYLAN LABORATORIES LTD | OLANZAPINE |
| 19168 | I | II | 2/10/2006 | CADILA HEALTHCARE LTD | OLANZAPINE |
| 19282 | A | II | 3/24/2006 | NEULAND LABORATORIES LTD | OLANZAPINE FORM-1 USP |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
