Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065431
Company: WOCKHARDT BIO AG

Products on ANDA 065431

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 065431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/25/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/065431s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2016	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 065431

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	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