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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208644
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG 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
04/24/2018 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
09/14/2022 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/14/2021 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/19/2018 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

RABEPRAZOLE SODIUM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACIPHEX RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 020973 WOODWARD
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 208644 ALKEM LABS LTD
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204179 AMNEAL PHARMS
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 205761 AUROBINDO PHARMA LTD
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 076824 DR REDDYS
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 090678 LANNETT CO INC
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 078964 LUPIN LTD
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 204237 RUBICON
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 076822 TEVA PHARMS USA
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 202376 TORRENT
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