Drugs@FDA: FDA-Approved Drugs

Abbreviated New Drug Application (ANDA): 077056
Company: TEVA

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

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/02/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/077056ltrTA.pdf

Action Date	Submission	Supplement Categories or Approval Type	Note
04/08/2015	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label is not available on this site.
12/05/2014	SUPPL-15	Labeling-Package Insert	Label is not available on this site.
12/05/2014	SUPPL-12	Labeling-Package Insert	Label is not available on this site.
05/03/2013	SUPPL-10	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide	Label is not available on this site.
10/03/2012	SUPPL-9	Labeling-Package Insert	Label is not available on this site.
10/03/2012	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert	Label is not available on this site.
07/31/2011	SUPPL-7	Labeling-Patient Package Insert, Labeling-Package Insert	Label is not available on this site.
03/31/2011	SUPPL-6	Labeling-Patient Package Insert, Labeling-Package Insert	Label is not available on this site.
03/31/2011	SUPPL-5	Labeling-Package Insert	Label is not available on this site.
05/21/2009	SUPPL-3	Labeling	Label is not available on this site.