An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211034
Company: DR REDDYS

Products on ANDA 211034

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211034

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/26/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211034

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

Top