Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201750
Company: HANSAMED INC
Company: HANSAMED INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ULTACAN FORTE | ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 4%;EQ 0.017MG BASE/1.7ML (4%; EQ 0.01MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | 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 |
---|---|---|---|---|---|---|---|
07/11/2017 | ORIG-1 | Approval |
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