Drug Master Files for: dipyridamole
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dipyridamole Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13870 | A | II | 11/27/1998 | MALGRAT PHARMA CHEMICALS SLU | DIPYRIDAMOLE |
| 14886 | I | II | 5/16/2000 | OMNICHEM NV | DIPYRIDAMOLE USP |
| 20416 | A | II | 4/6/2007 | ORCHID PHARMA LTD | DIPYRIDAMOLE |
| 22764 | I | II | 5/8/2009 | BOEHRINGER INGELHEIM LABSO CHIMIE FINE | DIPYRIDAMOLE |
| 23734 | I | II | 4/14/2010 | HAINAN POLY PHARMACEUTICAL CO LTD | ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE PELLETS CAPSULES |
| 24441 | A | II | 12/13/2010 | MYLAN LABORATORIES LTD | DIPYRIDAMOLE USP |
| 28566 | I | II | 8/14/2014 | YABAO PHARMACEUTICAL GROUP CO LTD | DIPYRIDAMOLE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
