Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022032
Company: DEXCEL PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 20MG 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
12/04/2007 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Letter (PDF)
Letter (PDF)
Review
Summary Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022032s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032_omeprazole_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022032s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/08/2019 SUPPL-41 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022032Orig1s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022032Orig1s041ltr.pdf
11/13/2017 SUPPL-38 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s038lbl.pdF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022032Orig1s038ltr.pdf
10/30/2017 SUPPL-37 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022032Orig1s037ltr.pdf
12/01/2016 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

02/10/2016 SUPPL-32 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022032Orig1s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022032Orig1s032ltr.pdf
02/08/2016 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/11/2015 SUPPL-29 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s029ltr.pdf
06/01/2015 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/30/2015 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/07/2015 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

01/05/2016 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/06/2015 SUPPL-24 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022032Orig1s024ltr.pdf
09/13/2013 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/16/2013 SUPPL-21 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022032Orig1s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022032Orig1s021ltr.pdf
10/29/2012 SUPPL-20 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s020ltr.pdf
09/10/2012 SUPPL-19 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032Orig1s019ltr.pdf
04/09/2012 SUPPL-16 Labeling-Container/Carton Labels, Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022032s016ltr.pdf
06/27/2011 SUPPL-12 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022032s012ltr.pdf
07/16/2010 SUPPL-8 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022032s008ltr.pdf
09/21/2009 SUPPL-4 Labeling-Container/Carton Labels

Label is not available on this site.

04/02/2009 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022032s003GenAdviceltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/08/2019 SUPPL-41 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022032Orig1s041lbl.pdf
11/13/2017 SUPPL-38 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s038lbl.pdF
10/30/2017 SUPPL-37 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022032Orig1s037lbl.pdf
02/10/2016 SUPPL-32 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022032Orig1s032lbl.pdf
06/11/2015 SUPPL-29 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s029lbll.pdf
03/06/2015 SUPPL-24 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022032Orig1s024lbl.pdf
08/16/2013 SUPPL-21 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022032Orig1s021lbl.pdf
10/29/2012 SUPPL-20 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022032Orig1s020lbl.pdf
04/02/2009 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022032s003lbl.pdf

OMEPRAZOLE

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; 20MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter Yes 022032 DEXCEL PHARMA
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter No 207740 DR REDDYS
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, DELAYED RELEASE;ORAL Over-the-counter No 207891 SUN PHARM

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