Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050757
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREVPAC AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30MG CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;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.cfm
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.cfm
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.cfm
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

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