FDA.reportPublic FDA data

Application 089475

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTAMINE SULFATEPROTAMINE SULFATEINJECTABLE;INJECTION10MG/MLNoNo
002PROTAMINE SULFATEPROTAMINE SULFATESOLUTION;INTRAVENOUS50MG/5ML (10MG/ML)NoNo

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
A089475-001PROTAMINE SULFATEPROTAMINE SULFATE250MG/25ML (10MG/ML)SOLUTION / INTRAVENOUS1986-11-05
A089475-002PROTAMINE SULFATEPROTAMINE SULFATE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS1988-06-07

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 22:54:322026-06A089475-001PROTAMINE SULFATE250MG/25ML (10MG/ML)SOLUTION / INTRAVENOUS1986-11-05a50c72e98297…
2026-08-01 22:54:322026-06A089475-002PROTAMINE SULFATE50MG/5ML (10MG/ML)SOLUTION / INTRAVENOUS1988-06-07a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCc76876da-b9a8-45d0-9278-7df3288d3a062025-04-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Protamine Sulfate
generic name: PROTAMINE SULFATE
Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLCe1964129-33f4-4e4e-86e3-8e6a4e65bd832025-02-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Protamine Sulfate
generic name: PROTAMINE SULFATE
Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLC7a31fc4c-579f-45cc-9559-39cfad9a57b32024-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Protamine Sulfate
generic name: PROTAMINE SULFATE
PROTAMINE SULFATEPROTAMINE SULFATEHF Acquisition Co LLC, DBA HealthFirst94d4f57f-940e-c0a8-e053-2a95a90ae3af2024-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PROTAMINE SULFATE
generic name: PROTAMINE SULFATE
Protamine SulfatePROTAMINE SULFATEFresenius Kabi USA, LLC8df0a819-9e1a-44ce-97a6-3ea82c867d442024-01-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Protamine Sulfate
generic name: PROTAMINE SULFATE