Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091414
Company: AIPING PHARM INC

Products on ANDA 091414

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 4MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No
MONTELUKAST SODIUM	MONTELUKAST SODIUM	EQ 5MG BASE	TABLET, CHEWABLE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091414

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/2012/091414Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/19/2022	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/04/2020	SUPPL-16	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
09/04/2020	SUPPL-14	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
10/01/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
07/26/2018	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/04/2015	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/04/2015	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/26/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
01/28/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.