Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065419
Company: TEVA PHARMS
Company: TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AZITHROMYCIN | AZITHROMYCIN | EQ 100MG BASE/5ML | FOR SUSPENSION;ORAL | Discontinued | None | No | No |
| AZITHROMYCIN | AZITHROMYCIN | EQ 200MG BASE/5ML | FOR SUSPENSION;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/24/2008 | 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 |
|---|---|---|---|---|---|
| 04/15/2020 | SUPPL-15 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/15/2020 | SUPPL-14 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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| 04/15/2020 | SUPPL-13 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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| 03/19/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2013 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/28/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/18/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/01/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/29/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/04/2010 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |