FDA.reportPublic FDA data

Application 022548

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYMAXIDGATIFLOXACINSOLUTION/DROPS;OPHTHALMIC0.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-3615ZYMAXIDgatifloxacinAllergan, Inc.NDACurrent
0023-3615ZYMAXIDgatifloxacinAllergan, Inc.NDACurrent
0023-3615ZYMAXIDgatifloxacinAllergan, Inc.NDACurrent
60758-615gatifloxacingatifloxacinPacific PharmaNDA AUTHORIZED Current
60758-615gatifloxacingatifloxacinPacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-615gatifloxacingatifloxacinPacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
73161SUPPL2023-01-17
45279SUPPL2016-09-12
45267SUPPL2016-09-08
24336ORIG2011-02-17
42556ORIG2010-12-08
38834ORIG2010-05-28
7525ORIG2010-05-21
53284ORIG1900-01-01
53283ORIG1900-01-01
53282ORIG1900-01-01