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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090372
Company: DR REDDYS LABS LTD

Products on ANDA 090372

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET;ORAL	Prescription	AB	No	No
ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090372

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/18/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090372s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/07/2014	SUPPL-2	Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
09/27/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090372

ZAFIRLUKAST

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACCOLATE	ZAFIRLUKAST	10MG	TABLET;ORAL	Prescription	Yes	AB	020547	STRIDES PHARMA
ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET;ORAL	Prescription	No	AB	212475	ANNORA PHARMA
ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET;ORAL	Prescription	No	AB	213163	AUROBINDO PHARMA
ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET;ORAL	Prescription	No	AB	090372	DR REDDYS LABS LTD
ZAFIRLUKAST	ZAFIRLUKAST	10MG	TABLET;ORAL	Prescription	No	AB	204928	RISING PHARMS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ACCOLATE	ZAFIRLUKAST	20MG	TABLET;ORAL	Prescription	Yes	AB	020547	STRIDES PHARMA
ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET;ORAL	Prescription	No	AB	212475	ANNORA PHARMA
ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET;ORAL	Prescription	No	AB	213163	AUROBINDO PHARMA
ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET;ORAL	Prescription	No	AB	090372	DR REDDYS LABS LTD
ZAFIRLUKAST	ZAFIRLUKAST	20MG	TABLET;ORAL	Prescription	No	AB	204928	RISING PHARMS

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