اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
ACIPHEX از شرکت EISAI INC
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| ACIPHEX | RABEPRAZOLE SODIUM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET, DELAYED RELEASE;ORAL | Discontinued |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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20973lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/27/2020 | SUPPL-41 | Labeling-Package Insert |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20973scf015ltr.pdf |
|
| 09/23/2002 | SUPPL-14 | Labeling |
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 |
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 |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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-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 | 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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