Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065098
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 | 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 |
---|---|---|---|---|---|---|---|
12/16/2002 | 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-25 | Labeling-Package Insert |
Label is not available on this site. |
||
02/23/2023 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2014 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
09/25/2014 | SUPPL-11 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
01/26/2011 | SUPPL-5 | Labeling |
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 |