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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218997
Company: AUROBINDO PHARMA LTD

Products on ANDA 218997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	AB	No	No
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	AB	No	No
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	AB	No	No
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218997

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/12/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218997

CIMETIDINE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	218997	AUROBINDO PHARMA LTD
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	218220	BIONPHARMA
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	074329	CHARTWELL MOLECULES
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	200MG	TABLET;ORAL	Prescription	No	AB	074151	TEVA

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	218997	AUROBINDO PHARMA LTD
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	218220	BIONPHARMA
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	074329	CHARTWELL MOLECULES
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	300MG	TABLET;ORAL	Prescription	No	AB	074151	TEVA

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	218997	AUROBINDO PHARMA LTD
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	218220	BIONPHARMA
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	074329	CHARTWELL MOLECULES
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	400MG	TABLET;ORAL	Prescription	No	AB	074151	TEVA

TABLET;ORAL; 800MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	218997	AUROBINDO PHARMA LTD
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	218220	BIONPHARMA
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	074329	CHARTWELL MOLECULES
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	074246	MYLAN
CIMETIDINE	CIMETIDINE	800MG	TABLET;ORAL	Prescription	No	AB	074463	TEVA

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