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 43.

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
2026-09-14 22:38:342026-08A215374-001AMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAP2025-08-2884e616aacf4f…
2026-08-18 06:07:402026-07A215374-001AMINOCAPROIC ACID250MG/MLINJECTABLE / INJECTIONAP2025-08-28caaa826d4ba7…
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
2026-09-14 22:38:342026-08A215374-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A215374-001AP1caaa826d4ba7…
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 2 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aminocaproic AcidAMINOCAPROIC ACIDAurobindo Pharma Limited48c6a773-7cde-4271-876a-4570a301f43a2022-09-27Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDBiocon Pharma Inc.9205fb6b-24a0-1138-fd7b-cc33d0df5d6f2021-08-12Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDVitruvias Therapeutics555a0910-dbeb-4643-8b3a-c9fe9b803b3c2021-03-15Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
AMINOCAPROIC ACIDAMINOCAPROIC ACIDBiocon Pharma Inc.c3cadb3a-4f63-06ee-0dd2-6828dbc1fffa2021-01-27Warnings, Adverse reactionsName fallback
brand name: AMINOCAPROIC ACID
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDCivica, Inc.36283eb3-f98e-446f-ade7-ce7864cd57792020-09-21Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDAmerican Regent, Inc.08bfb83e-3ac5-4e66-84a3-fcd4deaf73ae2020-07-16Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID
Aminocaproic AcidAMINOCAPROIC ACIDAmerican Regent, Inc.f4f65667-c349-420b-b7b7-f20f3a4e4d4e2019-12-06Warnings, Adverse reactionsName fallback
brand name: Aminocaproic Acid
generic name: AMINOCAPROIC ACID

Reported adverse events (FAERS/openFDA)#

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