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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202342
Company: BELCHER
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
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/2013/202342Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202342Orig1s000TAltr.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-Package Insert, Labeling-Medication Guide 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
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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202342s002lbl.pdf
12/19/2014 SUPPL-2 Labeling-Medication Guide 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
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