Drug Master Files for: DEXCHLORPHENIRAMINE MALEATE
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DEXCHLORPHENIRAMINE MALEATE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 21355 | A | II | 2/5/2008 | KESHAVA ORGANICS PVT LTD | DEXCHLORPHENIRAMINE MALEATE |
| 4298 | I | II | 10/22/1981 | SCHERING PLOUGH AVONDALE CO | DEXCHLORPHENIRAMINE MALEATE |
| 4688 | A | II | 10/16/1982 | KONGO CHEMICAL CO LTD | DEXCHLORPHENIRAMINE MALEATE |
| 5086 | I | II | 7/29/1983 | IRISH FINE CHEMICALS LTD | DEXCHLORPHENIRAMINE MALEATE |
| 5328 | I | II | 3/30/1984 | INDUSTRIA CHIMICA MILANESE SPA | DEXCHLORPHENIRAMINE MALEATE |
| 6922 | I | II | 4/10/1987 | HEXAGON LABORATORIES INC | DEXCHLORPHENIRAMINE MALEATE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
