FDA.reportPublic FDA data

Application 074613

Type
ANDA
Sponsor
TEVA PARENTERAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUMETANIDEBUMETANIDEINJECTABLE;INJECTION0.25MG/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
A074613-001BUMETANIDEBUMETANIDE0.25MG/MLINJECTABLE / INJECTION1997-11-18

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 22:54:322026-06A074613-001BUMETANIDE0.25MG/MLINJECTABLE / INJECTION1997-11-18a50c72e98297…

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BumetanideBUMETANIDEAnthea Pharma Private Limited9058fc52-f3f6-4d7f-b2a0-b1e2c714b1332026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDECardinal Health 107, LLCe7c3c63e-3aea-4b33-b165-7c74493596742026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDESandoz Inc8914d8bf-61b7-4cd2-a8ef-7e1c5df378282026-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEA-S Medication Solutionsa4dd156d-0f17-43d9-bf78-2d358c50681b2026-05-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEBryant Ranch Prepack43ab2dd6-39ba-4a53-aa84-d7975038ef432026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEBryant Ranch Prepack37179b2d-6589-40d8-8121-7561a6791d382026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDECardinal Health 107, LLC0a5577f5-d2fe-4b0d-8245-78ee77df30fd2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDECardinal Health 107, LLC9bd4fcd3-3020-41f2-b112-023b5db4487d2026-04-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDECardinal Health 107, LLC68f18d36-ffc2-4481-9286-914cfcf573a02026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEProficient Rx LP51d5f639-5d25-4ada-8bbe-ada2386173bf2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEProficient Rx LPae7dd557-f7a1-4d5a-b80e-3ca3a6e4943b2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDESun Pharmaceutical Industries, Inc.5c753aae-77b7-4add-8453-385a8f62d7db2026-03-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEAvPAK87385a0a-e7e6-8b7f-e053-2991aa0aa21a2026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEMullan Pharmaceutical Inc.b7cd724b-817b-4b45-8133-1ebf505867e72026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEFirst Nation Group, LLC79b77945-74a7-4cb5-8aa0-33a7babdf6d92026-02-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEA-S Medication Solutionsc8e243c0-805a-4d81-bec9-f5be6eb9f2bc2026-02-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDENovadoz Pharmaceuticals LLCcddd33fb-25b0-49ca-ab32-7c79a9b3a3842026-02-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEA-S Medication Solutionsb338ae20-fc07-4ec5-9e68-be636f75ce1a2026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
BumetanideBUMETANIDEA-S Medication Solutionsf4326e53-5217-48d4-a089-1184442049ac2026-02-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Bumetanide
generic name: BUMETANIDE
bumetanideBUMETANIDEA-S Medication Solutions8b5a38cc-1e76-4821-b286-31bad3bd69132026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: bumetanide
generic name: BUMETANIDE