FDA.reportPublic FDA data

Application 089307

Type
ANDA
Sponsor
QUAD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROTAMINE SULFATEPROTAMINE SULFATEInjectable; Injection50MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 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

Reported adverse events (FAERS/openFDA)#

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