FDA.reportPublic FDA data

Application 212470

Type
ANDA
Sponsor
JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUMETANIDEBUMETANIDETABLET;ORAL0.5MGNoNo
002BUMETANIDEBUMETANIDETABLET;ORAL1MGNoNo
003BUMETANIDEBUMETANIDETABLET;ORAL2MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212470-001BUMETANIDEBUMETANIDE0.5MGTABLET / ORALAB2025-08-05
A212470-002BUMETANIDEBUMETANIDE1MGTABLET / ORALAB2025-08-05
A212470-003BUMETANIDEBUMETANIDE2MGTABLET / ORALAB2025-08-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A212470-001AB
A212470-002AB
A212470-003AB

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 UTC2026-02A212470-001BUMETANIDE0.5MGTABLET / ORALAB2025-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212470-002BUMETANIDE1MGTABLET / ORALAB2025-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212470-003BUMETANIDE2MGTABLET / ORALAB2025-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212470-001BUMETANIDE0.5MGTABLET / ORALAB2025-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212470-002BUMETANIDE1MGTABLET / ORALAB2025-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212470-003BUMETANIDE2MGTABLET / ORALAB2025-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212470-001BUMETANIDE0.5MGTABLET / ORALAB2025-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212470-002BUMETANIDE1MGTABLET / ORALAB2025-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212470-003BUMETANIDE2MGTABLET / ORALAB2025-08-056a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212470-001BUMETANIDE0.5MGTABLET / ORALAB2025-08-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212470-002BUMETANIDE1MGTABLET / ORALAB2025-08-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212470-003BUMETANIDE2MGTABLET / ORALAB2025-08-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A212470-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212470-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A212470-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212470-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212470-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212470-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212470-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212470-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A212470-003AB16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212470-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212470-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212470-003AB1a50c72e98297…

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 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