FDA.reportPublic FDA data

Application 021706

Type
NDA
Sponsor
SANTARUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEGERIDOMEPRAZOLE; SODIUM BICARBONATEFOR SUSPENSION; ORAL40MG/PACKET;1.68GM/PACKETYesNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZEGERIDOMEPRAZOLE AND SODIUM BICARBONATESantarus, Inc..cd6868b9-5824-442b-8d65-4db29ecb70a42023-07-19Warnings, Adverse reactionsName fallback
brand name: ZEGERID

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44145ORIG2011-12-20
42278ORIG2005-10-06
37492ORIG2004-12-29
28422ORIG2004-12-29