FDA.reportPublic FDA data

Application 019270

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETOPTICBETAXOLOL HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61314-245Betaxolol HydrochlorideBetaxolol HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-245Betaxolol HydrochlorideBetaxolol HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
61314-245Betaxolol HydrochlorideBetaxolol HydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57630ORIG2019-02-15
33714SUPPL2006-02-22
1268SUPPL2006-02-22