U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 211368
Company: INGENUS PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
03/01/2019 ORIG-1 Approval STANDARD

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-4 Labeling-Package Insert

Label is not available on this site.

06/09/2022 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/20/2019 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

PANTOPRAZOLE SODIUM

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
Back to Top