Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065064
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 | 500MG;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 |
|---|---|---|---|---|---|---|---|
| 03/15/2002 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/65064ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/01/2022 | SUPPL-45 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/22/2014 | SUPPL-34 | Labeling-Container/Carton Labels, 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-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/26/2006 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 07/31/2006 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 06/02/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/13/2002 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 08/21/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLET;ORAL; 500MG;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 | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 091569 | AUROBINDO PHARMA LTD |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 205707 | MICRO LABS LTD INDIA |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065064 | SANDOZ |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065117 | SANDOZ INC |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 500MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065101 | TEVA |