Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021850
Company: SANTARUS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZEGERID MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE 700MG;20MG;600MG TABLET, CHEWABLE;ORAL Discontinued None No No
ZEGERID MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE 700MG;40MG;600MG TABLET, CHEWABLE;ORAL Discontinued None No 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
03/24/2006 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021850s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021850s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2010 SUPPL-3 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s009,021849s004,021850s003,022456s002ltr.pdf
01/20/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021850s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021636s008,021849s003,021850s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/03/2010 SUPPL-3 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf
01/20/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021850s002lbl.pdf

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