Drug Master Files for: AZELASTINE HYDROCHLORIDE
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AZELASTINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15361 | A | II | 3/29/2001 | GEDEON RICHTER PLC | AZELASTINE HCL USP |
| 15440 | A | II | 5/15/2001 | EVONIK NUTRITION AND CARE GMBH | AZELASTINE HYDROCHLORIDE |
| 18398 | A | II | 6/1/2005 | DAITO PHARMACEUTICALS CO LTD | AZELASTINE HYDROCHLORIDE USP |
| 19422 | A | II | 5/5/2006 | EUTICALS SPA | AZELASTINE HYDROCHLORIDE |
| 20186 | I | II | 6/26/2008 | CIPLA LTD | AZELASTINE HYDROCHLORIDE BP/PH.EUR |
| 20314 | A | II | 2/12/2007 | URQUIMA SA | AZELASTINE HCL |
| 22427 | A | II | 1/20/2009 | ESTEVE QUIMICA SA | AZELASTINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
