Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202776
Company: MYLAN PHARMS INC

Products on ANDA 202776

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE/PACKET	GRANULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202776

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2012	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
08/18/2020	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/22/2019	SUPPL-9	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/22/2019	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
10/08/2015	SUPPL-5	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/08/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.