Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;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 |
---|---|---|---|---|---|---|---|
06/05/2002 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65066ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/065066.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/22/2014 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2014 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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09/22/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
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06/28/2011 | SUPPL-28 | Labeling |
Label is not available on this site. |
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05/29/2009 | SUPPL-23 | Labeling |
Label is not available on this site. |
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11/25/2014 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
01/14/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/02/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
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11/26/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR SUSPENSION;ORAL; 200MG/5ML;EQ 28.5MG BASE/5ML
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 | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201090 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065191 | HIKMA PHARMS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 205187 | MICRO LABS LTD INDIA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065066 | SANDOZ |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065098 | SANDOZ INC |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 200MG/5ML;EQ 28.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065089 | TEVA |
FOR SUSPENSION;ORAL; 400MG/5ML;EQ 57MG BASE/5ML
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 | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201090 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210416 | DEVA HOLDING AS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065191 | HIKMA PHARMS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 205187 | MICRO LABS LTD INDIA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065066 | SANDOZ |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065098 | SANDOZ INC |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 400MG/5ML;EQ 57MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065089 | TEVA |