FDA.reportPublic FDA data

Application 022288

Type
NDA
Sponsor
BAUSCH AND LOMB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BEPREVEBEPOTASTINE BESILATESOLUTION/DROPS;OPHTHALMIC1.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-629Beprevebepotastine besilateBausch & Lomb IncorporatedNDACurrent
24208-630Bepotastine Besilatebepotastine besilateBausch & Lomb IncorporatedNDA AUTHORIZED GENERICCurrent
82260-630Bepotastine Besilatebepotastine besilateBausch & Lomb Americas Inc.NDA AUTHORIZED GENERICCurrent
82260-630Bepotastine Besilatebepotastine besilateBausch & Lomb Americas Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52547SUPPL2018-02-09
52530SUPPL2018-02-09
38516SUPPL2012-06-29
7183SUPPL2012-06-29
44726ORIG2009-10-21
42480ORIG2009-10-21
17205ORIG2009-09-18
7182ORIG2009-09-16
53192ORIG1900-01-01
53191ORIG1900-01-01
53190ORIG1900-01-01