Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021281
Company: TAKEDA PHARMS NA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREVACID LANSOPRAZOLE 15MG/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Discontinued None No No
PREVACID LANSOPRAZOLE 30MG/PACKET FOR SUSPENSION, DELAYED RELEASE;ORAL Discontinued None No 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
05/03/2001 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid_Aprov.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/31/2009 SUPPL-26 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-24 Labeling 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-22 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-21 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-17 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-14 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/2004/021281_s014_PREVACID DELAYED REL CAPS.pdf
06/15/2004 SUPPL-13 Labeling

Label is not available on this site.

08/05/2003 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf
08/30/2002 SUPPL-7 Labeling 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
12/03/2002 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

12/03/2002 SUPPL-4 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021281_S004_PREVACID.pdf
03/07/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/2002 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf
12/07/2001 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
07/31/2009 SUPPL-26 Supplement Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf
10/28/2008 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf
06/14/2007 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf
04/12/2006 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf
06/17/2004 SUPPL-14 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 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf
05/03/2002 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf
05/03/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf

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