Drugs@FDA: FDA-Approved Drugs
Company: WAYLIS THERAP
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ACIPHEX | RABEPRAZOLE SODIUM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|
07/18/2023 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020973s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020973Orig1s043ltr.pdf | |
03/04/2022 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020973s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020973Orig1s042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020973Orig1s042ltr.pdf | |
11/27/2020 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020973s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020973Orig1s041ltr.pdf | |
06/07/2018 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020973Orig1s039ltr.pdf | |
01/09/2018 | SUPPL-38 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020973Orig1s038ltr.pdf | |
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-Package Insert, Labeling-Medication Guide |
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 |
---|---|---|---|---|---|
07/18/2023 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020973s043lbl.pdf | |
03/04/2022 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020973s042lbl.pdf | |
11/27/2020 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020973s041lbl.pdf | |
06/07/2018 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s039lbl.pdf | |
01/09/2018 | SUPPL-38 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020973s038lbl.pdf | |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf | |
12/19/2014 | SUPPL-35 | Labeling-Medication Guide | 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 | WAYLIS THERAP |
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 |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 078964 | CHARTWELL RX |
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 | 204237 | RUBICON |
RABEPRAZOLE SODIUM | RABEPRAZOLE SODIUM | 20MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 202376 | TORRENT |