FDA.reportPublic FDA data

Application 021262

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALPHAGAN PBRIMONIDINE TARTRATESOLUTION/DROPS;OPHTHALMIC0.15%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9177ALPHAGAN Pbrimonidine tartrateAllergan, Inc.NDACurrent
0023-9177ALPHAGAN Pbrimonidine tartrateAllergan, Inc.NDACurrent
0023-9177ALPHAGAN Pbrimonidine tartrateAllergan, Inc.NDACurrent
0023-9177ALPHAGAN Pbrimonidine tartrateAllergan, Inc.NDACurrent
82182-773Brimonidine tartratebrimonidine tartratePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83400SUPPL 2025-09-19
83393SUPPL 2025-09-19
14780SUPPL2010-08-28
27259SUPPL2010-08-16
27258SUPPL2006-05-25
14779SUPPL2006-05-24
42062SUPPL2004-05-27
42061ORIG2004-05-27
27257SUPPL2004-02-27
4823SUPPL2004-02-27
27256SUPPL2001-12-20
14778SUPPL2001-12-20
36501ORIG2001-03-16
27255ORIG2001-03-16