Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021428
Company: TAKEDA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREVACID LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription AB Yes No
PREVACID LANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, 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
08/30/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/2018 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf
06/07/2018 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s087, s088, 021428Orig1s034, s035ltr.pdf
04/13/2018 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020406Orig1s084,021428Orig1s032ltr.pdf
10/18/2017 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020406Orig1s083,021428Orig1s031ltr.pdf
10/24/2016 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf
12/19/2014 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf
12/16/2015 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf
05/03/2012 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf
09/28/2012 SUPPL-25 Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf
05/20/2011 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf
10/28/2011 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076,021428s023ltr.pdf
06/01/2011 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf
09/03/2010 SUPPL-21 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf
05/12/2010 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf
07/31/2009 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf
10/28/2008 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf
04/21/2008 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf
06/14/2007 SUPPL-12 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf
04/12/2006 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf
06/17/2004 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021428_S004_PREVACID DELAYED RELEASE CAPS.pdf
06/15/2004 SUPPL-3 Labeling

Label is not available on this site.

08/05/2003 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/07/2018 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf
06/07/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s087s088,021428s034s035lbl.pdf
04/13/2018 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020406s084,021428s032lbl.pdf
10/18/2017 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020406s083,021428s031lbl.pdf
10/24/2016 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf
12/16/2015 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf
12/19/2014 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf
12/19/2014 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf
09/28/2012 SUPPL-25 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf
05/03/2012 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf
10/28/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf
06/01/2011 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf
05/20/2011 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf
09/03/2010 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf
05/12/2010 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf
07/31/2009 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf
10/28/2008 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf
06/14/2007 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf
04/12/2006 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf
06/17/2004 SUPPL-4 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf
08/30/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf

PREVACID

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANSOPRAZOLE LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription No AB 202396 MYLAN
LANSOPRAZOLE LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription No AB 208784 TEVA PHARMS USA
LANSOPRAZOLE LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription No AB 200816 ZYDUS PHARMS
PREVACID LANSOPRAZOLE 15MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription Yes AB 021428 TAKEDA PHARMS USA

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LANSOPRAZOLE LANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription No AB 202396 MYLAN
LANSOPRAZOLE LANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription No AB 208784 TEVA PHARMS USA
LANSOPRAZOLE LANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription No AB 200816 ZYDUS PHARMS
PREVACID LANSOPRAZOLE 30MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Prescription Yes AB 021428 TAKEDA PHARMS USA

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