FDA.reportPublic FDA data

Application 209937

Type
ANDA
Sponsor
CUSTOPHARM INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM TETRADECYL SULFATESODIUM TETRADECYL SULFATEINJECTABLE;INJECTION60MG/2ML (30MG/ML)NoNo

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
A209937-001SODIUM TETRADECYL SULFATESODIUM TETRADECYL SULFATE60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAP2019-12-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209937-001AP

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 22:54:322026-06A209937-001SODIUM TETRADECYL SULFATE60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAP2019-12-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A209937-001AP1a50c72e98297…

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
Sodium Tetradecyl SulfateSODIUM TETRADECYL SULFATEHikma Pharmaceuticals USA Inc.997394e1-ec1f-4093-e053-2a95a90a0ea02024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209937
application number: ANDA209937
ndc (product): 24201-201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-201Sodium Tetradecyl SulfateSodium Tetradecyl SulfateLeucadia PharmaceuticalsANDACurrent
24201-201Sodium Tetradecyl SulfateSodium Tetradecyl SulfateLeucadia PharmaceuticalsANDACurrent
24201-201Sodium Tetradecyl SulfateSodium Tetradecyl SulfateHikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)ANDACurrent