Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077058
Company: SUN PHARM

Products on ANDA 077058

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 077058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/10/2007	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
04/08/2015	SUPPL-16	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/10/2014	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
04/30/2013	SUPPL-10	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
01/17/2012	SUPPL-9	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/29/2011	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
07/29/2011	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
08/31/2009	SUPPL-4	Labeling		Label is not available on this site.