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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022456
Company: SANTARUS

Summary Review

Products on NDA 022456

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	343MG;20MG;750MG	TABLET;ORAL	Discontinued	None	No	No
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE	343MG;40MG;750MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022456

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/04/2009	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/2009/022456lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022456s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456_magnsium_hydroxide_omeprazole_sodium_bicarbonate_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022456s000sumr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/23/2012	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456s006ltr.pdf
12/11/2012	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022456Orig1s005ltr.pdf
12/07/2011	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022456s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s004ltr.pdf
05/20/2011	SUPPL-3	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022456s003ltr.pdf
09/03/2010	SUPPL-2	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

Labels for NDA 022456

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/11/2012	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s005lbl.pdf
05/23/2012	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022456s006lbl.pdf
12/07/2011	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022456s004lbl.pdf
09/03/2010	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021636s009,021849s004,021850s003,022456s002lbl.pdf
12/04/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022456lbl.pdf

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