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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209400
Company: DEXCEL

Products on NDA 209400

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209400

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
10/21/2022	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209400Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209400Orig1s012ltr.pdf
11/13/2020	SUPPL-10	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209400Orig1s010ltr.pdf
04/29/2020	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209400Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209400Orig1s007ltr.pdf
07/07/2021	SUPPL-6	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209400Orig1s006ltr.pdf
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

Labels for NDA 209400

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/21/2022	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209400Orig1s012lbl.pdf
04/29/2020	SUPPL-7	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209400Orig1s007lbl.pdf
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

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

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

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