Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078980
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | EQ 20MG BASE/10ML (EQ 2MG BASE/ML) | INJECTABLE;INJECTION | Discontinued | None | No | No |
MITOXANTRONE HYDROCHLORIDE | MITOXANTRONE HYDROCHLORIDE | EQ 30MG BASE/15ML (EQ 2MG 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 |
---|---|---|---|---|---|---|---|
04/13/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/20/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |