Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 090901
Company: JUBILANT GENERICS
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
08/30/2011 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
12/07/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/21/2014 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/30/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

10/16/2012 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

10/16/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

10/16/2012 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert

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 090807 APOTEX INC
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 090901 JUBILANT GENERICS
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 200821 MACLEODS PHARMS LTD
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 077056 TEVA
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
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 090807 APOTEX INC
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 090901 JUBILANT GENERICS
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 200821 MACLEODS PHARMS LTD
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 077056 TEVA
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
PROTONIX PANTOPRAZOLE SODIUM EQ 40MG BASE TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020987 WYETH PHARMS

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