Drugs@FDA: FDA-Approved Drugs

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

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

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
01/03/2020 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
01/03/2020 SUPPL-23 Labeling-Package Insert, Labeling-Medication Guide

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-Package Insert, Labeling-Medication Guide

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-Package Insert, Labeling-Patient Package Insert, Labeling-Container/Carton Labels

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.

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 203024 L PERRIGO CO
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 ORCHID HLTHCARE
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 090970 MYLAN PHARMS INC
PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE;ORAL Prescription No AB 202052 ORCHID HLTHCARE
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

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