Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202472
Company: ACTAVIS INC
Company: ACTAVIS INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/5ML | INJECTABLE;INTRAVENOUS | 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 |
---|---|---|---|---|---|---|---|
03/04/2013 | 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 |
---|---|---|---|---|---|
05/04/2021 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
05/04/2021 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
11/18/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
10/21/2014 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |