Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050757
Company: TAKEDA PHARMS USA
Company: TAKEDA PHARMS USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PREVPAC (COPACKAGED) | AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE | 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/02/1997 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/050757a.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/07/2018 | SUPPL-22 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050757s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/050757Orig1s022ltr.pdf | |
| 11/29/2017 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050757Orig1s021ltr.pdf |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050757s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050757Orig1s020ltr.pdf | |
| 12/19/2014 | SUPPL-19 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050757s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050757Orig1s019ltr.pdf | |
| 03/01/2017 | SUPPL-18 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050757Orig1s018ltr.pdf | |
| 11/06/2013 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050757s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050757Orig1s017ltr.pdf | |
| 04/01/2009 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050757s016ltr.pdf |
| 10/30/2007 | SUPPL-15 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050757s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s015ltr.pdf | |
| 05/31/2007 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050757s014ltr.pdf |
| 08/09/2006 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012, 050757s013LTR.pdf |
| 08/09/2006 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050757s012, 050757s013LTR.pdf |
| 04/20/2005 | SUPPL-11 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050757s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050757s011ltr.pdf | |
| 07/27/2004 | SUPPL-10 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf |
| 07/27/2004 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50757s009,010ltr.pdf |
| 11/22/2002 | SUPPL-8 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50757slr006,008ltr.pdf | |
| 03/12/2002 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/22/2002 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50757slr006,008ltr.pdf | |
| 02/27/2001 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s004_Prevpac.html | |
| 08/20/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s003_Prevpac.html | |
| 01/22/1999 | SUPPL-2 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50757s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50757s2ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757s002_Prevpac.html | |
| 01/09/1998 | 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 |
|---|---|---|---|---|---|
| 06/07/2018 | SUPPL-22 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050757s022lbl.pdf | |
| 11/29/2017 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s021lbl.pdf |
| 03/01/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s018lbl.pdf | |
| 03/01/2017 | SUPPL-18 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050757s018lbl.pdf | |
| 10/24/2016 | SUPPL-20 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050757s020lbl.pdf | |
| 12/19/2014 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050757s019lbl.pdf | |
| 11/06/2013 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050757s017lbl.pdf | |
| 10/30/2007 | SUPPL-15 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050757s015lbl.pdf | |
| 04/20/2005 | SUPPL-11 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050757s011lbl.pdf | |
| 11/22/2002 | SUPPL-8 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf | |
| 11/22/2002 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50757slr006,008_prevpac_lbl.pdf | |
| 10/22/1999 | SUPPL-4 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S004_Prevpac_prntlbl.pdf | |
| 08/20/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/50-757S003_Prevpac_prntlbl.pdf | |
| 01/22/1999 | SUPPL-2 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50757s2lbl.pdf |