Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021706
Company: SANTARUS

• Other Important Information from FDA

Products on NDA 21706

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZEGERID	OMEPRAZOLE; SODIUM BICARBONATE	40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION; ORAL	Discontinued	None	Yes	No

Labels for NDA 021706

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/21/2004	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021706lbl.pdf