Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065096
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 10/29/2002 | 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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-39 | Labeling, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/24/2024 | SUPPL-36 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 04/24/2024 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/04/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/26/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/08/2013 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/09/2011 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/02/2009 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 02/02/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 04/06/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/02/2004 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 11/13/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/08/2003 | SUPPL-7 | Labeling |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLET;ORAL; 875MG;EQ 125MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 091568 | AUROBINDO PHARMA LTD |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 209991 | DEVA HOLDING AS |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 203824 | HIKMA PHARMS |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 204755 | MICRO LABS LTD INDIA |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065063 | SANDOZ |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065093 | SANDOZ INC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065096 | TEVA PHARMS USA |
| AUGMENTIN '875' | AMOXICILLIN; CLAVULANATE POTASSIUM | 875MG;EQ 125MG BASE | TABLET;ORAL | Prescription | Yes | AB | 050720 | US ANTIBIOTICS |