Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203808
Company: EDENBRIDGE PHARMS

Products on ANDA 203808

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	AB	No	No
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203808

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/2015	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2022	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203808

TINIDAZOLE

TABLET;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TINDAMAX	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	Yes	AB	021618	MISSION PHARMA
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	203808	EDENBRIDGE PHARMS
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	202044	NOVEL LABS INC
TINIDAZOLE	TINIDAZOLE	250MG	TABLET;ORAL	Prescription	No	AB	202489	UNIQUE PHARM LABS

TABLET;ORAL; 500MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TINDAMAX	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	Yes	AB	021618	MISSION PHARMA
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	203808	EDENBRIDGE PHARMS
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	202044	NOVEL LABS INC
TINIDAZOLE	TINIDAZOLE	500MG	TABLET;ORAL	Prescription	No	AB	202489	UNIQUE PHARM LABS