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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210374
Company: DEVA HOLDING AS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
11/29/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

AMOXICILLIN AND CLAVULANATE POTASSIUM

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 065431 CIPLA
AMOXICILLIN AND CLAVULANATE POTASSIUM AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 210374 DEVA HOLDING AS
AUGMENTIN '250' AMOXICILLIN; CLAVULANATE POTASSIUM 250MG/5ML;EQ 62.5MG BASE/5ML FOR SUSPENSION;ORAL Prescription Yes AB 050575 US ANTIBIOTICS
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