Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209400
Company: DEXCEL PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Over-the-counter 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
07/05/2017 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209400Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209400Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209400Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/28/2019 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209400Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209400Orig1s005ltr.pdf
07/12/2018 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s003Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s003Ltr.pdf
06/12/2018 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s002ltr.pdf
02/28/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209400Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/28/2019 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209400Orig1s005lbl.pdf
07/12/2018 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s003Lbl.pdf
06/12/2018 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s002lbl.pdf
02/28/2018 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209400Orig1s001lbl.pdf
07/05/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209400Orig1s000lbl.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, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL; 20MG
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
OMEPRAZOLE OMEPRAZOLE 20MG TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL Over-the-counter Yes 209400 DEXCEL PHARMA

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