FDA.reportPublic FDA data

Application 019845

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BETOPTIC SBETAXOLOL HYDROCHLORIDESUSPENSION/DROPS;OPHTHALMICEQ 0.25% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0246Betoptic Sbetaxolol hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0246Betoptic Sbetaxolol hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0246Betoptic Sbetaxolol hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0246Betoptic Sbetaxolol hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-0246Betoptic Sbetaxolol hydrochlorideAlcon Laboratories, Inc.NDACurrent
0078-0729Betoptic Sbetaxolol hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67763SUPPL2021-06-11
67754SUPPL2021-06-10
47102SUPPL2017-02-06
47087SUPPL2017-02-01
47080SUPPL2017-01-31
11767SUPPL2008-06-12
19742SUPPL2008-05-14
19741SUPPL2007-06-14
34015SUPPL2007-06-12
19291SUPPL2003-06-08
11766SUPPL2003-05-29
53082SUPPL1900-01-01
53081SUPPL1900-01-01
51784SUPPL1900-01-01