Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019810
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRILOSEC OMEPRAZOLE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None Yes No
PRILOSEC OMEPRAZOLE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None Yes No
PRILOSEC OMEPRAZOLE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE, DELAYED REL PELLETS;ORAL Discontinued None Yes No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
09/14/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/24/2016 SUPPL-103 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s103,022056Orig1s020ltr.pdf
12/19/2016 SUPPL-102 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019810Orig1s102,022056Orig1s019ltr.pdf
12/19/2014 SUPPL-101 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s101,022056Orig1s017ltr.pdf
02/25/2014 SUPPL-99 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s099,022056Orig1s015ltr.pdf
03/27/2014 SUPPL-98 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019810Orig1s098,022056Orig1s014ltr.pdf
05/15/2013 SUPPL-97 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019810Orig1s097,022056Orig1s013ltr.pdf
09/28/2012 SUPPL-96 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s096,022056Orig1s012ltr.pdf
10/09/2012 SUPPL-95 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810Orig1s095,022056Orig1s011ltr.pdf
01/20/2012 SUPPL-94 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019810s094,022056s010ltr.pdf
05/20/2011 SUPPL-93 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s093,022056s009ltr.pdf
01/20/2011 SUPPL-92 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019810s092,022056s008ltr.pdf
06/30/2011 SUPPL-91 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022056s007,019810s091ltr.pdf
09/03/2010 SUPPL-90 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s090,022056s005ltr.pdf
03/03/2010 SUPPL-88 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019810s088,022056s003ltr.pdf
12/01/2008 SUPPL-87 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019810s087, 022056s001ltr.pdf
04/27/2007 SUPPL-85 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019810s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019810s085ltr.pdf
09/25/2006 SUPPL-84 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s084LTR.pdf
01/26/2006 SUPPL-83 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019810s083ltr.pdf
03/07/2005 SUPPL-82 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19810s082lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19810s082ltr.pdf
10/09/2003 SUPPL-80 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf
12/19/2002 SUPPL-77 Manufacturing (CMC)-Control

Label is not available on this site.

12/16/2002 SUPPL-76 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19180slr076ltr.pdf
05/10/2001 SUPPL-75 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/12/2002 SUPPL-74 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19810s074lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810se5074ltr.pdf
10/30/2001 SUPPL-73 Labeling

Label is not available on this site.

08/10/2000 SUPPL-72 Manufacturing (CMC)-Control

Label is not available on this site.

02/04/2002 SUPPL-71 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/27/2000 SUPPL-70 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

07/27/2000 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2000 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

10/09/2003 SUPPL-67 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19810slr067,080ltr.pdf
05/16/2001 SUPPL-66 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/10/1999 SUPPL-65 Manufacturing (CMC)

Label is not available on this site.

03/16/2000 SUPPL-64 Manufacturing (CMC)

Label is not available on this site.

08/08/2000 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

02/23/2000 SUPPL-62 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19810-S062_Prilosec.pdf
02/14/2002 SUPPL-61 Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19810s061ltr.pdf
05/18/1999 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/2000 SUPPL-59 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/23/2004 SUPPL-58 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19810se8-058,slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019810_S003_S058_PRILOSEC.pdf
02/03/1999 SUPPL-57 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19810-S57_Prilosec.pdf
07/10/1998 SUPPL-56 Manufacturing (CMC)-Packaging Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm
06/30/1998 SUPPL-55 Efficacy-Labeling Change With Clinical Data

Label is not available on this site.

12/01/1998 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1998 SUPPL-53 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/30/1998 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/17/1997 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1998 SUPPL-50 Manufacturing (CMC)-Packaging Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm
09/03/1997 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

04/15/1997 SUPPL-48 Labeling

Label is not available on this site.

02/18/1999 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

04/04/1997 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

04/18/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

08/09/1996 SUPPL-41 Labeling

Label is not available on this site.

09/11/1996 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1998 SUPPL-38 Manufacturing (CMC)-Formulation Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019810s38s50s56.cfm
04/15/1996 SUPPL-37 Efficacy-New Indication

Label is not available on this site.

11/26/1996 SUPPL-36 Efficacy-New Indication Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019810ap.pdf
03/09/1995 SUPPL-35 Labeling

Label is not available on this site.

11/09/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/22/1996 SUPPL-33 Efficacy-New Indication

Label is not available on this site.

03/23/1995 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/31/1995 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

01/20/1995 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/29/1994 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/19/1995 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/16/1995 SUPPL-24 Labeling

Label is not available on this site.

10/05/1995 SUPPL-23 Labeling

Label is not available on this site.

03/09/1995 SUPPL-22 Labeling

Label is not available on this site.

12/22/1993 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/13/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-19 Efficacy-New Indication

Label is not available on this site.

11/04/1997 SUPPL-18 Labeling

Label is not available on this site.

06/29/1993 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/15/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/21/1992 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/19/1993 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1993 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

03/09/1995 SUPPL-10 Labeling

Label is not available on this site.

03/09/1995 SUPPL-9 Labeling

Label is not available on this site.

01/27/1992 SUPPL-8 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019810_S008_OMEPRAZOLE_AP.pdf
01/03/1991 SUPPL-7 Labeling

Label is not available on this site.

07/19/1990 SUPPL-6 Labeling

Label is not available on this site.

09/14/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/23/2004 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19810se8-058,slr003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019810_S003_S058_PRILOSEC.pdf
06/12/1991 SUPPL-2 Efficacy-New Indication

Label is not available on this site.

10/26/1989 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/19/2016 SUPPL-102 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s102,022056s019lbl.pdf
10/24/2016 SUPPL-103 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019810s103,022056s020lbl.pdf
12/19/2014 SUPPL-101 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf
12/19/2014 SUPPL-101 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022056s017lbl019810s101lbl.pdf
03/27/2014 SUPPL-98 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s098,022056s014lbl.pdf
02/25/2014 SUPPL-99 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019810s099,022056s015lbl.pdf
05/15/2013 SUPPL-97 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019810s097,022056s013lbl.pdf
10/09/2012 SUPPL-95 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s095,022056s011lbl.pdf
09/28/2012 SUPPL-96 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s096lbl.pdf
01/20/2012 SUPPL-94 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019810s094,022056s010lbledt.pdf
06/30/2011 SUPPL-91 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022056s007,019810s091lbl.pdf
05/20/2011 SUPPL-93 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s093,022056s009lbl.pdf
01/20/2011 SUPPL-92 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019810s092,022056s008lbl.pdf
09/03/2010 SUPPL-90 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf
03/03/2010 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s088,022056s003lbl.pdf
12/01/2008 SUPPL-87 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022056s001019810s087lbl.pdf
04/27/2007 SUPPL-85 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019810s085lbl.pdf
09/25/2006 SUPPL-84 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s084lbl.pdf
01/26/2006 SUPPL-83 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019810s083lbl.pdf
03/07/2005 SUPPL-82 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19810s082lbl.pdf
02/23/2004 SUPPL-58 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf
02/23/2004 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058,slr003_prilosec_lbl.pdf
10/09/2003 SUPPL-80 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf
10/09/2003 SUPPL-67 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19810slr067,080_prilosec_lbl.pdf
07/12/2002 SUPPL-74 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19810s074lbl.pdf

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