An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 202342
Company: BELCHER

Medication Guide

Products on NDA 202342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	24.65MG	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No
ESOMEPRAZOLE STRONTIUM	ESOMEPRAZOLE STRONTIUM	49.3MG	CAPSULE, DELAYED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/06/2013	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD	Label (PDF) Letter (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202342s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202342Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2022	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202342s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202342Orig1s007ltr.pdf
11/27/2020	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202342s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202342Orig1s006ltr.pdf
06/07/2018	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202342s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202342Orig1s005ltr.pdf
10/24/2016	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202342s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202342Orig1s003ltr.pdf
12/19/2014	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202342s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202342Orig1s002ltr.pdf

Labels for NDA 202342

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202342s007lbl.pdf
11/27/2020	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202342s006lbl.pdf
06/07/2018	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202342s005lbl.pdf
10/24/2016	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202342s003lbl.pdf
12/19/2014	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202342s002lbl.pdf
12/19/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202342s002lbl.pdf
08/06/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202342s000lbl.pdf

Top