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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021850
Company: SANTARUS

Other Important Information from FDA

Products on NDA 021850

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021850

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

Labels for NDA 021850

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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