Drug Master Files for: aripiprazole
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aripiprazole Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15651 | I | II | 10/5/2001 | BRISTOL MYERS SQUIBB CO | ARIPIPRAZOLE TABLETS |
| 18471 | I | II | 6/30/2005 | DR REDDYS LABORATORIES LTD | ARIPIPRAZOLE |
| 18706 | A | II | 8/15/2005 | ERREGIERRE SPA | ARIPIPRAZOLE USP-EP |
| 18774 | A | II | 9/13/2005 | CAMBREX CHARLES CITY INC | ARIPIPRAZOLE |
| 19203 | I | II | 2/14/2006 | IND SWIFT LABORATORIES LTD | ARIPIPRAZOLE |
| 19554 | A | II | 6/28/2006 | MYLAN LABORATORIES LTD | ARIPIPRAZOLE USP |
| 19682 | I | II | 8/11/2006 | SYNTHON BV | ARIPIPRAZOLE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
