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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210416
Company: DEVA HOLDING AS

Products on ANDA 210416

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210416

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/11/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210416

AMOXICILLIN AND CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL; 400MG/5ML;EQ 57MG 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	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	201090	AUROBINDO PHARMA LTD
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	210416	DEVA HOLDING AS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065191	HIKMA PHARMS
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	205187	MICRO LABS LTD INDIA
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065066	SANDOZ
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065098	SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM	AMOXICILLIN; CLAVULANATE POTASSIUM	400MG/5ML;EQ 57MG BASE/5ML	FOR SUSPENSION;ORAL	Prescription	No	AB	065089	TEVA

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