Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019810
Company: ASTRAZENECA
Company: ASTRAZENECA
| 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| PRILOSEC | OMEPRAZOLE | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| PRILOSEC | OMEPRAZOLE | 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |
| PRILOSEC | OMEPRAZOLE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, DELAYED REL PELLETS;ORAL | Discontinued | None | Yes | No |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 |