Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076724
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE | ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | EQ 0.083% BASE;0.017% | SOLUTION;INHALATION | 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 |
|---|---|---|---|---|---|---|---|
| 12/31/2007 | 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 |
|---|---|---|---|---|---|
| 12/29/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/13/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/21/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/11/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |