Drug Master Files for: ROPIVACAINE HYDROCHLORIDE
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ROPIVACAINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 18288 | A | II | 4/15/2005 | EXCELLA GMBH AND CO KG | ROPIVACAINE HYDROCHLORIDE |
| 19084 | A | II | 12/30/2005 | NAVINTA LLC | ROPIVACAINE |
| 20249 | A | II | 2/2/2007 | CHEMWERTH INC | ROPIVACAINE HCL MONOHYDRATE |
| 20654 | A | II | 7/3/2007 | FINE CHEMICALS CORP PTY LTD | ROPIVACAINE HYDROCHLORIDE |
| 22023 | A | II | 9/22/2008 | DISHMAN CARBOGEN AMCIS LTD | ROPIVACAINE HYDROCHLORIDE ANHYDROUS |
| 23239 | A | II | 11/2/2009 | FINE CHEMICALS CORP PTY LTD | ROPIVACAINE |
| 24948 | A | II | 10/12/2011 | JUBILANT GENERICS LTD | ROPIVACAINE 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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
