FDA.reportPublic FDA data

Application 215374

Type
ANDA
Sponsor
ZENARA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMINOCAPROIC ACIDAMINOCAPROIC ACIDINJECTABLE;INJECTION250MG/MLNoNo

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
A215374-001AMINOCAPROIC ACIDAMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAP2025-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215374-001AP

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
2026-02-19 14:30 UTC2026-02A215374-001AMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAP2025-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215374-001AMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAP2025-08-2831067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215374-001AMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAP2025-08-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215374-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215374-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215374-001AP1a50c72e98297…

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 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aminocaproic acidAMINOCAPROIC ACIDAmneal Pharmaceuticals LLC4a22e559-2dac-42d7-af8d-eb0ebbc2f76d2026-07-28Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDBryant Ranch Prepackc2144bf8-1a26-4958-ba10-5358bd69cd232026-05-19Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDAmerican Health Packaging4c2612ab-86a4-4c54-a5c0-e837f755965f2026-05-19Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDHospira, Inc.1c5bc1dd-e9ec-44c1-9281-67ad482315d92026-04-30Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic acidAMINOCAPROIC ACIDBPI LABS LLCcfa601c4-b649-417e-a301-b246f080f1eb2026-01-05Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDFlorida Pharmaceutical Products, LLC828568a7-1808-4330-b466-01889b2311a22025-12-20Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDMedical Purchasing Solutions, LLC4629d585-134b-a479-e063-6294a90a34322025-12-17Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDHenry Schein, Inc.5ff09f58-c225-4792-9f1e-9d2b7a4135212025-07-11Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDApozeal Pharmaceuticals Inc.15aa2f36-ccc6-431a-99a2-45d812ef4bbf2025-06-14Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic acidAMINOCAPROIC ACIDMajor Pharmaceuticals2612ee97-1723-40f2-99e6-3a736f63200f2025-03-28Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS7d08ad63-71f5-4286-9622-84295668a2932025-01-08Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDVitruvias Therapeuticsd9f615a0-119c-4553-93a7-b30025b5fe142024-07-18Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDMedical Purchasing Solutions, LLC15eadaf4-5801-8044-e063-6394a90a72cf2024-04-12Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDCarnegie Pharmaceuticals, LLC0d6560a3-c67e-428e-b9b8-fab538856b412024-03-05Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDHikma Pharmaceuticals USA Inc.7b8f0ddb-00fd-4c22-afae-afe636f95f3a2024-01-08Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic acidAMINOCAPROIC ACIDAmneal Pharmaceuticals NY LLC65efb08a-c1ae-4bb7-a8a2-b7ae264855672023-11-01Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID
Aminocaproic acidAMINOCAPROIC ACIDNovadoz Pharmaceuticals LLCc5dc0c33-a0f9-43c4-9f10-3668f4361b872023-09-06Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID
Aminocaproic acidAMINOCAPROIC ACIDNovadoz Pharmaceuticals LLC8a0d4fa5-8608-4e83-b5c7-d7e088d802812023-09-01Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDCarnegie Pharmaceuticals, LLC871ec401-30f8-4154-a16e-b82dc1e04b492023-04-20Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic acidAMINOCAPROIC ACIDTruPharma LLCafffd309-3819-07c6-e053-2995a90a948b2022-11-17Warnings, Adverse reactionsName fallback
brand name: Aminocaproic acid
generic name: AMINOCAPROIC ACID