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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211117
Company: EDENBRIDGE PHARMS

Products on ANDA 211117

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211117

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211117

ALBENDAZOLE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	208094	ACTAVIS ELIZABETH
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	215652	ALEMBIC
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	211034	DR REDDYS
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	211117	EDENBRIDGE PHARMS
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	213435	MSN
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	210011	STRIDES PHARMA
ALBENDAZOLE	ALBENDAZOLE	200MG	TABLET;ORAL	Prescription	No	AB	208979	ZYDUS PHARMS

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