FDA.reportPublic FDA data

Application 021764

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QOLIANABRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.15%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-144Brimonidine TartrateBrimonidine TartrateSandoz IncNDACurrent
61314-144Brimonidine TartrateBrimonidine TartrateSandoz IncNDACurrent
61314-144Brimonidine TartrateBrimonidine TartrateSandoz IncNDACurrent
63629-8792Brimonidine TartrateBrimonidine TartrateBryant Ranch PrepackNDACurrent
63629-8792Brimonidine TartrateBrimonidine TartrateBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84295SUPPL 2025-11-25
84270SUPPL 2025-11-24
37607SUPPL2012-03-28
6142SUPPL2012-03-28
37606SUPPL2010-08-10
28551SUPPL2010-08-06
42303ORIG2008-02-22
28550ORIG2006-05-25
16331ORIG2006-05-24