Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022016
Company: CUMBERLAND PHARMS
Company: CUMBERLAND PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VAPRISOL | CONIVAPTAN HYDROCHLORIDE | 20MG | INJECTABLE; INJECTION | Prescription | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
02/28/2007 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022016s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022016_vaprisol_toc.cfm |