Drugs@FDA: FDA-Approved Drugs
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-Package Insert, Labeling |
Label is not available on this site. |
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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. |
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11/04/2014 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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09/26/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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07/08/2013 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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04/26/2013 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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06/09/2011 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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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. |
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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. |
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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 |