Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210410
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BENDAMUSTINE HYDROCHLORIDE | BENDAMUSTINE HYDROCHLORIDE | 100MG/4ML (25MG/ML) | SOLUTION;IV (INFUSION) | None (Tentative Approval) | 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 |
---|---|---|---|---|---|---|---|
11/13/2018 | ORIG-1 | Tentative Approval | STANDARD |
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