Application 019921

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OCUFLOXOFLOXACINSOLUTION/DROPS;OPHTHALMIC0.3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11980-779OCUFLOXofloxacinAllergan, Inc.NDACurrent
11980-779OCUFLOXofloxacinAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45904SUPPL2016-11-17
45903SUPPL2016-11-16
20424SUPPL2006-10-26
53116ORIG1900-01-01
53115ORIG1900-01-01
53114ORIG1900-01-01