Drug Master Files for: DEXMEDETOMIDINE HYDROCHLORIDE
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DEXMEDETOMIDINE HYDROCHLORIDE Drug Master Files
| DMF No. | Status | Type | Submission Date | Holder | Subject |
|---|---|---|---|---|---|
| 13810 | A | II | 10/30/1998 | FERMION OY | DEXMEDETOMIDINE HYDROCHLORIDE |
| 22681 | A | II | 3/31/2009 | ALCAMI WISCONSIN CORP | DEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071) |
| 23132 | A | II | 9/28/2009 | RELIABLE BIOPHARMACEUTICAL LLC | DEXMEDETOMIDINE HCI |
| 23232 | A | II | 10/30/2009 | GLAND PHARMA LTD | DEXMEDETOMIDINE HYDROCHLORIDE USP |
| 24202 | A | II | 12/15/2011 | CHEMWERTH INC | DEXMEDETOMIDINE HCL |
| >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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
