Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065066
Company: SANDOZ
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 |
|---|---|---|---|---|---|
| 05/01/2024 | SUPPL-50 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2024 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 05/29/2009 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 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. |
||
| 06/02/2005 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 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 |