FDA.reportPublic FDA data

Application 040541

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOTRADECOLSODIUM TETRADECYL SULFATEINJECTABLE;INJECTION20MG/2ML (10MG/ML)NoYes
002SOTRADECOLSODIUM TETRADECYL SULFATEINJECTABLE;INJECTION60MG/2ML (30MG/ML)NoYes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040541-001SOTRADECOLSODIUM TETRADECYL SULFATE20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12
A040541-002SOTRADECOLSODIUM TETRADECYL SULFATE60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040541-002AP

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 22:54:322026-06A040541-001SOTRADECOL20MG/2ML (10MG/ML)INJECTABLE / INJECTIONRS2004-11-12a50c72e98297…
2026-08-01 22:54:322026-06A040541-002SOTRADECOL60MG/2ML (30MG/ML)INJECTABLE / INJECTIONAPRS2004-11-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040541-002AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM TETRADECYL SULFATESODIUM TETRADECYL SULFATEHF Acquisition Co LLC, DBA HealthFirstc76f4b3b-9f93-349f-e053-2995a90a2d572024-02-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040541
application number: ANDA040541
ndc (product): 51662-1562
SotradecolTETRADECYL HYDROGEN SULFATE (ESTER)Mylan Institutional LLCf1756c28-dcd2-4b49-be62-07ca206820182021-08-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040541
application number: ANDA040541
ndc (product): 67457-163
ndc (product): 67457-162
(SOTRADECOL) SODIUM TETRADECYL SULFATE(SOTRADECOL) SODIUM TETRADECYL SULFATEHF Acquisition Co LLC, DBA HealthFirstc59db022-bda8-1732-e053-2a95a90a24f82021-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040541
application number: ANDA040541
ndc (product): 51662-1563

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4525Sotradecoltetradecyl hydrogen sulfate (ester)A-S Medication SolutionsANDACurrent
50090-4529Sotradecoltetradecyl hydrogen sulfate (ester)A-S Medication SolutionsANDACurrent
51662-1562SODIUM TETRADECYL SULFATESODIUM TETRADECYL SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1563(SOTRADECOL) SODIUM TETRADECYL SULFATE(SOTRADECOL) SODIUM TETRADECYL SULFATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
67457-162Sotradecoltetradecyl hydrogen sulfate (ester)Mylan Institutional LLCANDACurrent
67457-162Sotradecoltetradecyl hydrogen sulfate (ester)Mylan Institutional LLCANDACurrent
67457-162Sotradecoltetradecyl hydrogen sulfate (ester)Mylan Institutional LLCANDACurrent
67457-163Sotradecoltetradecyl hydrogen sulfate (ester)Mylan Institutional LLCANDACurrent
67457-163Sotradecoltetradecyl hydrogen sulfate (ester)Mylan Institutional LLCANDACurrent
67457-163Sotradecoltetradecyl hydrogen sulfate (ester)Mylan Institutional LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7670ORIG2004-11-16