Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078281
Company: LANNETT CO INC

Products on ANDA 078281

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 078281

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2011	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
06/09/2022	SUPPL-32	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/21/2022	SUPPL-30	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/21/2022	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2020	SUPPL-24	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2020	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2020	SUPPL-22	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2020	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/03/2020	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
04/08/2015	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/10/2014	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
12/10/2013	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
05/24/2013	SUPPL-13	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
05/24/2013	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
05/18/2012	SUPPL-11	Labeling-Container/Carton Labels		Label is not available on this site.
01/17/2012	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
01/17/2012	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
08/05/2014	SUPPL-6	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078281

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	091231	ATLANTIDE
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	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
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	091231	ATLANTIDE
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	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
PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE;ORAL	Prescription	Yes	AB	020987	WYETH PHARMS