FDA.reportPublic FDA data

Application 200740

Type
NDA
Sponsor
LEADIANT BIOSCI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYSTARANCYSTEAMINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.44% BASEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N200740-001CYSTARANCYSTEAMINE HYDROCHLORIDEEQ 0.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2012-10-02

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N200740-001CYSTARANEQ 0.44% BASESOLUTION/DROPS / OPHTHALMICRLD, RS2012-10-02a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CYSTARANCYSTEAMINE HYDROCHLORIDELeadiant Biosciences, Inc.b98ee838-ed23-42a9-93b5-72579e490fba2025-04-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 200740
application number: NDA200740
ndc (product): 54482-020

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent
54482-020CYSTARANcysteamine hydrochlorideLeadiant Biosciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70347SUPPL2022-03-02
70290SUPPL2022-02-28
62698SUPPL2020-04-28
62690SUPPL2020-04-27
44827ORIG2013-08-26
43355ORIG2013-08-26
18979ORIG2012-10-04
9848ORIG2012-10-04