Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065358
Company: SANDOZ INC
Company: SANDOZ INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG 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 |
---|---|---|---|---|---|---|---|
08/13/2007 | 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 |
---|---|---|---|---|---|
06/24/2024 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
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10/23/2023 | SUPPL-20 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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01/27/2020 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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01/30/2012 | SUPPL-4 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
10/29/2014 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR SUSPENSION;ORAL; 600MG/5ML;EQ 42.9MG 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 | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 201091 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065420 | CIPLA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209351 | DEVA HOLDING AS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065373 | HIKMA PHARMS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 217805 | MICRO LABS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065358 | SANDOZ INC |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065162 | TEVA |
AUGMENTIN ES-600 | AMOXICILLIN; CLAVULANATE POTASSIUM | 600MG/5ML;EQ 42.9MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050755 | US ANTIBIOTICS |