FDA.reportPublic FDA data

Application 019219

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002BETAGANLEVOBUNOLOL HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-4385BETAGANlevobunolol hydrochlorideAllergan, Inc.NDACurrent
0023-4385BETAGANlevobunolol hydrochlorideAllergan, Inc.NDACurrent
0023-4385BETAGANlevobunolol hydrochlorideAllergan, Inc.NDACurrent
60758-060LEVOBUNOLOL HYDROCHLORIDElevobunolol hydrochloridePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-060LEVOBUNOLOL HYDROCHLORIDElevobunolol hydrochloridePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent
60758-060LEVOBUNOLOL HYDROCHLORIDElevobunolol hydrochloridePacific Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57629ORIG2019-02-15
50931SUPPL2017-12-27
50912SUPPL2017-12-27
11454SUPPL2003-04-15