Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020973
Company: EISAI INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACIPHEX RABEPRAZOLE SODIUM 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET, DELAYED RELEASE;ORAL Discontinued None Yes No
ACIPHEX RABEPRAZOLE SODIUM 20MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/19/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20973ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20973_Aciphex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s037ltr.pdf
12/19/2014 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf
10/15/2014 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf
04/04/2016 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s033lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf
04/19/2013 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020973Orig1s032ltr.pdf
05/08/2012 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973s030ltr.pdf
10/05/2012 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020973Orig1s029ltr.pdf
05/20/2011 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020973s028ltr.pdf
09/03/2010 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020973s025ltr.pdf
06/30/2008 SUPPL-22 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020973se5-022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/020973se022_SUMR.pdf
06/03/2005 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020973s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020973s020ltr.pdf
08/01/2003 SUPPL-16 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20973slr016ltr.pdf
09/30/2002 SUPPL-15 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973scf015ltr.pdf
09/23/2002 SUPPL-14 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973slr014ltr.pdf
11/08/2002 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21456,20973se8-013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021456_aciphex.cfm
05/29/2002 SUPPL-12 Manufacturing (CMC)-Formulation Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s012ltr.pdf
10/02/2001 SUPPL-11 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/02/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/12/2002 SUPPL-9 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973s009ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020973Orig1s009.pdf
08/15/2001 SUPPL-8 Labeling Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020973_S008_ACIPHEX_DELAYED_RELEASE_TABS.pdf
12/15/2000 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/20/2000 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/28/2000 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/2000 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/16/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/16/2000 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/21/1999 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/24/2016 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s037lbl.pdf
04/04/2016 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020973s033lbledt.pdf
12/19/2014 SUPPL-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf
12/19/2014 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf
10/15/2014 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf
04/19/2013 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020973s032lbl.pdf
10/05/2012 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s029lbl.pdf
05/08/2012 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020973s030lbl.pdf
05/20/2011 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020973s028lbl.pdf
09/03/2010 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020973s025lbl.pdf
06/30/2008 SUPPL-22 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020973s022lbl.pdf
06/03/2005 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020973s020lbl.pdf
11/08/2002 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973S013lbl.pdf
02/12/2002 SUPPL-9 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20973s009lbl.pdf
08/15/2001 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20973s8lbl.pdf
08/19/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf

ACIPHEX

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 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 KREMERS URBAN PHARMS
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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