Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021229
Company: ASTRAZENECA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRILOSEC OTC OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter None 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
06/20/2003 ORIG-1 Approval Type 2 - New Active Ingredient and Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21229ltr_Prilosec.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-229_Prilosec.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2018 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021229Orig1s032ltr.pdf
04/03/2018 SUPPL-31 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021229Orig1s031ltr.pdf
10/12/2016 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021229Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021229Orig1s029ltr.pdf
05/15/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

06/22/2015 SUPPL-26 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021229Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021229Orig1s026ltr.pdf
09/06/2013 SUPPL-25 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021229Orig1s025ltr.pdf
09/13/2012 SUPPL-24 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021229Orig1s024ltr.pdf
08/29/2011 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s023ltr.pdf
06/16/2011 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/22/2011 SUPPL-21 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s021ltr.pdf
06/20/2011 SUPPL-20 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s020ltr.pdf
02/25/2011 SUPPL-19 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021229s019ltr.pdf
12/20/2010 SUPPL-17 Labeling-Package Insert, Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s017ltr.pdf
07/06/2010 SUPPL-14 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021229s014ltr.pdf
09/09/2009 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021229s013ltr.pdf
06/18/2008 SUPPL-10 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s010ltr.pdf
02/29/2008 SUPPL-9 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s009ltr.pdf
01/18/2008 SUPPL-8 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021229s008ltr.pdf
03/19/2007 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021229s006ltr.pdf
10/02/2006 SUPPL-5 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021229s005LTR.pdf
12/20/2004 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21229s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21229s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/12/2018 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s032lbl.pdf
04/03/2018 SUPPL-31 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021229Orig1s031lbl.pdf
10/12/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021229Orig1s029lbl.pdf
06/22/2015 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021229Orig1s026lbl.pdf
09/06/2013 SUPPL-25 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021229Orig1s025lbl.pdf
08/29/2011 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021229Orig1s023lbl.pdf
03/19/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021229s006lbl.pdf
10/02/2006 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021229s005lbl.pdf
12/20/2004 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21229s002lbl.pdf
06/20/2003 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21229lbl_Part2.pdf

PRILOSEC OTC

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET, DELAYED RELEASE;ORAL; EQ 20MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter No 206877 AUROBINDO PHARMA LTD
OMEPRAZOLE MAGNESIUM OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter No 204152 PERRIGO R AND D
PRILOSEC OTC OMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter Yes 021229 ASTRAZENECA PHARMS

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