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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090934
Company: ACCORD HLTHCARE

Products on ANDA 090934

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/03/2011	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
04/02/2021	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/02/2021	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
02/13/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
02/13/2015	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
05/15/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
07/19/2014	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090934

LETROZOLE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FEMARA	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	Yes	AB	020726	NOVARTIS PHARMS
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	No	AB	090934	ACCORD HLTHCARE
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	No	AB	205869	BEIJING YILING
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	No	AB	091191	CARNEGIE
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	No	AB	211717	EUGIA PHARMA
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	No	AB	200161	NATCO PHARMA LTD
LETROZOLE	LETROZOLE	2.5MG	TABLET;ORAL	Prescription	No	AB	090289	TEVA PHARMS

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