Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091509
Company: SUN PHARM

Products on ANDA 091509

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LANSOPRAZOLE	LANSOPRAZOLE	30MG	CAPSULE, DELAYED REL PELLETS;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091509

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2013	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
09/02/2022	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
10/20/2020	SUPPL-19	Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
10/20/2020	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/20/2020	SUPPL-10	Labeling		Label is not available on this site.
10/20/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
04/23/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/02/2015	SUPPL-6	Labeling-Package Insert		Label is not available on this site.