Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209371
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 125MG/5ML;EQ 31.25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | AB | No | No |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG/5ML;EQ 62.5MG 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 |
---|---|---|---|---|---|---|---|
04/19/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209371Orig1s000ltr.pdf |
AMOXICILLIN AND CLAVULANATE POTASSIUM
FOR SUSPENSION;ORAL; 125MG/5ML;EQ 31.25MG 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 | 125MG/5ML;EQ 31.25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209371 | AUROBINDO PHARMA |
AUGMENTIN '125' | AMOXICILLIN; CLAVULANATE POTASSIUM | 125MG/5ML;EQ 31.25MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050575 | US ANTIBIOTICS |
FOR SUSPENSION;ORAL; 250MG/5ML;EQ 62.5MG 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 | 250MG/5ML;EQ 62.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 209371 | AUROBINDO PHARMA |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG/5ML;EQ 62.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 210374 | DEVA HOLDING AS |
AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG/5ML;EQ 62.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | No | AB | 065431 | WOCKHARDT BIO AG |
AUGMENTIN '250' | AMOXICILLIN; CLAVULANATE POTASSIUM | 250MG/5ML;EQ 62.5MG BASE/5ML | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 050575 | US ANTIBIOTICS |