Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090797
Company: ACTAVIS TOTOWA

Products on ANDA 090797

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090797

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/07/2011	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
03/13/2024	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/13/2024	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
03/13/2024	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/13/2024	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/30/2013	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
05/30/2013	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
03/23/2012	SUPPL-4	Labeling-Package Insert		Label is not available on this site.