Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 208979
Company: ZYDUS PHARMS

Products on ANDA 208979

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 208979

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/14/2018	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/25/2020	SUPPL-1	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 208979

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	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