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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019845-001BETOPTIC SBETAXOLOL HYDROCHLORIDEEQ 0.25% BASESUSPENSION/DROPS / OPHTHALMICRLD, RS1989-12-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N019845-001BETOPTIC SEQ 0.25% BASESUSPENSION/DROPS / OPHTHALMICRLD, RS1989-12-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019845-001BETOPTIC SEQ 0.25% BASESUSPENSION/DROPS / OPHTHALMICRLD, RS1989-12-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019845-001BETOPTIC SEQ 0.25% BASESUSPENSION/DROPS / OPHTHALMICRLD, RS1989-12-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N019845-001BETOPTIC SEQ 0.25% BASESUSPENSION/DROPS / OPHTHALMICRLD, RS1989-12-29a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Betoptic SBETAXOLOL HYDROCHLORIDENovartis Pharmaceuticals Corporation905ba189-456c-4aa4-8231-39a971374ad82025-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 019845
application number: NDA019845
ndc (product): 0078-0729

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

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