Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076822
Company: TEVA PHARMS USA
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
11/08/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076822Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076822Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2015 SUPPL-4 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/03/2015 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/08/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076822Orig1s000lbl.pdf

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 EISAI INC
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 204237 BRECKENRIDGE PHARM
RABEPRAZOLE SODIUM RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 076824 DR REDDYS LABS LTD
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 076885 MYLAN PHARMS INC
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 PHARMS LTD

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