Drug Master Files for: levocetirizine dihydrochloride
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levocetirizine dihydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 20173 | A | II | 1/17/2007 | CIPLA LTD | LEVOCETIRIZINE DIHYDROCHLORIDE USP |
| 21005 | A | II | 11/2/2007 | DR REDDYS LABORATORIES LTD | LEVOCETIRIZINE DIHYDROCLORIDE USP |
| 21110 | A | II | 12/6/2007 | GLOCHEM INDUSTRIES PRIVATE LTD | LEVOCETIRIZINE DIHYDROCHLORIDE USP |
| 21214 | A | II | 1/4/2008 | SUN PHARMACEUTICAL INDUSTRIES LTD | Levocetirizine Dihydrochloride |
| 21417 | A | II | 3/11/2008 | RA CHEM PHARMA LTD | LEVOCETIRIZINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
