Drug Master Files for: CETIRIZINE HYDROCHLORIDE
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CETIRIZINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 15145 | A | II | 11/17/2000 | CIPLA LTD | CETIRIZINE DIHYDROCHLORIDE USP |
| 15219 | I | II | 12/22/2000 | CAMBREX CHARLES CITY INC | CETIRIZINE DIHYDROCHLORIDE |
| 16244 | A | II | 11/14/2002 | WAVELENGTH ENTERPRISES LTD | CETIRIZINE DIHYDROCHLORIDE |
| 16262 | A | II | 11/27/2002 | TARO PHARMACEUTICAL INDUSTRIES LTD | CETIRIZINE DIHYDROCHLORIDE USP |
| 17513 | A | II | 6/18/2004 | UCB FARCHIM SA | CETIRIZINE HYDROCHLORIDE |
| 17741 | A | II | 10/8/2004 | MYLAN LABORATORIES LTD | CETIRIZINE HYDROCHLORIDE USP |
| 17889 | A | II | 12/14/2004 | SUN PHARMACEUTICAL INDUSTRIES LTD | CETIRIZINE DIHYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
