Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202038
Company: AUROBINDO PHARMA LTD

Products on ANDA 202038

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	Prescription	AB	No	No
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202038

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/28/2012	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2023	SUPPL-25	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/09/2022	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/09/2022	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/14/2019	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/14/2019	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/14/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/14/2019	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
04/04/2016	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
04/08/2015	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/02/2015	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/13/2013	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
06/13/2013	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202038

PANTOPRAZOLE SODIUM

TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090797	ACTAVIS TOTOWA
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	205119	AMNEAL PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202038	AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	077619	DR REDDYS LABS LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217282	GRANULES
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202882	HETERO LABS LTD V
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	078281	LANNETT CO INC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090970	MYLAN PHARMS INC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202052	ORBION PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090807	RUBICON
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090074	TORRENT PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091231	WOCKHARDT BIO AG
PROTONIX	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020987	WYETH PHARMS

TABLET, DELAYED RELEASE;ORAL; EQ 40MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090797	ACTAVIS TOTOWA
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	205119	AMNEAL PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202038	AUROBINDO PHARMA LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	077619	DR REDDYS LABS LTD
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	217282	GRANULES
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202882	HETERO LABS LTD V
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	211368	INGENUS PHARMS LLC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	078281	LANNETT CO INC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	215880	MANKIND PHARMA
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090970	MYLAN PHARMS INC
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	202052	ORBION PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090807	RUBICON
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	090074	TORRENT PHARMS
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	No	AB	091231	WOCKHARDT BIO AG
PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020987	WYETH PHARMS