Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090955
Company: TEVA PHARMS

Products on ANDA 090955

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 090955

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2012	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090955Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2023	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
10/04/2023	SUPPL-14	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/08/2019	SUPPL-13	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/08/2019	SUPPL-12	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/08/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/28/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
04/28/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/26/2013	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
02/06/2013	SUPPL-4	Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
12/17/2012	SUPPL-2	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.