Drugs@FDA: FDA-Approved Drugs

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

Products on ANDA 077056

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 077056

Original Approvals or Tentative Approvals

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

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/11/2022	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2022	SUPPL-25	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide		Label is not available on this site.
08/11/2022	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2022	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
08/11/2022	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2022	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/11/2022	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
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-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels		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-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
07/31/2011	SUPPL-7	Labeling-Package Insert, Labeling-Patient 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.