Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207920
Company: ASTRAZENECA LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEXIUM 24HR ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE 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
11/23/2015 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207920Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207920Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207920Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207920Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/04/2019 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207920Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207920Orig1s005ltr.pdf
12/18/2017 SUPPL-2 Labeling-Container/Carton Labels Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/207920Orig1s002.pdf
02/03/2017 SUPPL-1 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207920orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/04/2019 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207920Orig1s005lbl.pdf
12/18/2017 SUPPL-2 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920Orig1s002lbl.pdf
02/03/2017 SUPPL-1 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207920orig1s001lbl.pdf
11/23/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207920Orig1s000lbl.pdf

NEXIUM 24HR

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; EQ 20MG BASE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
NEXIUM 24HR ESOMEPRAZOLE MAGNESIUM EQ 20MG BASE TABLET, DELAYED RELEASE;ORAL Over-the-counter Yes 207920 ASTRAZENECA LP

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