FDA.reportPublic FDA data

Application 203168

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROLENSABROMFENAC SODIUMSOLUTION/DROPS;OPHTHALMICEQ 0.07% ACIDYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24208-602ProlensaBromfenac SodiumBausch & Lomb IncorporatedNDACurrent
24208-602ProlensaBromfenac SodiumBausch & Lomb IncorporatedNDACurrent
24208-602ProlensaBromfenac SodiumBausch & Lomb IncorporatedNDACurrent
24208-602ProlensaBromfenac SodiumBausch & Lomb IncorporatedNDACurrent
24208-602ProlensaBromfenac SodiumBausch & Lomb IncorporatedNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81287SUPPL 2025-02-19
81272SUPPL 2025-02-18
24429ORIG2013-07-15
22914ORIG2013-07-15
10176ORIG2013-04-10
19439ORIG2013-04-09