Drug Master Files for: desloratadine
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desloratadine Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 17652 | A | II | 9/7/2004 | MOREPEN LABORATORIES LTD | DESLORATADINE |
| 19014 | A | II | 12/8/2005 | SUN PHARMACEUTICAL INDUSTRIES LTD | DESLORATADINE |
| 19083 | A | II | 12/27/2005 | LUPIN LTD | DESLORATADINE USP |
| 19182 | I | II | 5/18/2006 | CIPLA LTD | DESLORATADINE |
| 19339 | A | II | 4/11/2006 | ORCHID PHARMA LTD | DESLORATADINE |
| 19403 | A | II | 5/2/2006 | TEVA PHARMACEUTICAL INDUSTRIES LTD | DESLORATADINE DRUG SUBSTANCE |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
