Drug Master Files for: meclizine hydrochloride
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meclizine hydrochloride Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 19419 | A | II | 4/28/2006 | SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD | MECLIZINE HYDROCHLORIDE |
| 20470 | A | II | 4/23/2007 | FLEMING LABORATORIES LTD | MECLIZINE HCL USP |
| 21987 | A | II | 12/5/2008 | JUBILANT GENERICS LTD | MECLIZINE HYDROCHLORIDE |
| 22309 | A | II | 12/11/2008 | RA CHEM PHARMA LTD | MECLIZINE HYDROCHLORIDE USP |
| 22933 | A | II | 7/8/2009 | SRIKEM LABORATORIES PVT LTD | MECLIZINE HYDROCHLORIDE USP |
| 23372 | A | II | 12/15/2009 | SRI KRISHNA PHARMACEUTICALS LTD | MECLIZINE HYDROCHLORIDE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
