FDA.reportPublic FDA data

Application 021565

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELESTATEPINASTINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-9201ELESTATepinastine hydrochlorideAllergan, Inc.NDACurrent
0023-9201ELESTATepinastine hydrochlorideAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
15781SUPPL2011-12-23
28120SUPPL2011-12-22
28119SUPPL2005-08-19
37228SUPPL2005-08-16
42211ORIG2003-12-31
15780ORIG2003-10-17
5740ORIG2003-10-14