Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091170
Company: BRECKENRIDGE
Company: BRECKENRIDGE
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 |
---|---|---|---|---|---|
02/21/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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02/21/2020 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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03/24/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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03/25/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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03/25/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
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03/31/2014 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |