Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 091569
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | AB | No | No |
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 |
---|---|---|---|---|---|---|---|
01/20/2012 | 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 |
---|---|---|---|---|---|
04/03/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
07/23/2015 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLET;ORAL; 250MG;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 | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 091569 | AUROBINDO PHARMA LTD |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 205707 | MICRO LABS LTD INDIA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG;EQ 125MG BASE | TABLET;ORAL | Prescription | No | AB | 065189 | SANDOZ |
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 | 209992 | DEVA HOLDING AS |
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 |