Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065155
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 05/31/2005 | 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 |
|---|---|---|---|---|---|
| 08/16/2023 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/10/2023 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/10/2023 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/10/2023 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/10/2023 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/10/2023 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 12/11/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/18/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/30/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/30/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/20/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/13/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/04/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 06/30/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 05/08/2006 | SUPPL-1 | Labeling |
Label is not available on this site. |