Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065205
Company: TEVA
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG;EQ 28.5MG BASE | TABLET, CHEWABLE;ORAL | Prescription | None | No | No |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG;EQ 57MG BASE | TABLET, CHEWABLE;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/09/2005 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/065205_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/26/2014 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/20/2014 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/29/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/20/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/28/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |