Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021850
Company: SANTARUS

• Other Important Information from FDA

Products on NDA 21850

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

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