Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200821
Company: MACLEODS PHARMS LTD

Products on ANDA 200821

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 200821

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/16/2012	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
06/07/2023	SUPPL-26	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
09/13/2019	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/13/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/23/2016	SUPPL-7	Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
04/09/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/12/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/12/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.