Application 019404

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCUFENFLURBIPROFEN SODIUMSOLUTION/DROPS;OPHTHALMIC0.03%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-023FLURBIPROFEN SODIUMflurbiprofen sodiumRebel Distributors CorpNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57636ORIG2019-02-15
1315SUPPL2012-07-30
33739SUPPL2012-07-26
1314SUPPL2004-06-10
11499SUPPL2003-08-28
33738SUPPL2003-04-15
33737SUPPL2003-04-15