FDA.reportPublic FDA data

Application 217239

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TORSEMIDETORSEMIDETABLET;ORAL5MGNoNo
002TORSEMIDETORSEMIDETABLET;ORAL10MGNoNo
003TORSEMIDETORSEMIDETABLET;ORAL20MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217239-001TORSEMIDETORSEMIDE5MGTABLET / ORALAB2026-05-01
A217239-002TORSEMIDETORSEMIDE10MGTABLET / ORALAB2026-05-01
A217239-003TORSEMIDETORSEMIDE20MGTABLET / ORALAB2026-05-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217239-001AB
A217239-002AB
A217239-003AB

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
2026-09-14 22:38:342026-08A217239-001TORSEMIDE5MGTABLET / ORALAB2026-05-0184e616aacf4f…
2026-09-14 22:38:342026-08A217239-002TORSEMIDE10MGTABLET / ORALAB2026-05-0184e616aacf4f…
2026-09-14 22:38:342026-08A217239-003TORSEMIDE20MGTABLET / ORALAB2026-05-0184e616aacf4f…
2026-08-18 06:07:402026-07A217239-001TORSEMIDE5MGTABLET / ORALAB2026-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07A217239-002TORSEMIDE10MGTABLET / ORALAB2026-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07A217239-003TORSEMIDE20MGTABLET / ORALAB2026-05-01caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217239-001TORSEMIDE5MGTABLET / ORALAB2026-05-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217239-002TORSEMIDE10MGTABLET / ORALAB2026-05-01a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217239-003TORSEMIDE20MGTABLET / ORALAB2026-05-01a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217239-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A217239-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A217239-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A217239-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217239-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A217239-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217239-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217239-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217239-003AB1a50c72e98297…

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 2 of 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TorsemideTORSEMIDEAurobindo Pharma Limited55e88727-864e-4313-860c-31a6ca45168f2024-05-08Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDERising Pharma Holdings, Inc.3c8f1c0b-8a44-4ca0-b2cf-3c591f8878fd2024-05-08Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEAphena Pharma Solutions - Tennessee, LLC159e8c90-ebc6-0991-e063-6394a90aae192024-04-08Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEGolden State Medical Supply, Inc.a6055317-8826-df85-e053-2a95a90a53782023-12-28Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEHikma Pharmaceuticals USA Inc.fde1d1be-0faa-440a-9039-bdb103288c762023-08-31Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.03fbbb85-4e0f-4f3b-b4b0-87f84cb33d472023-06-30Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEA-S Medication Solutions3e9c6ee1-c49f-4f59-9391-8a9b57becb022023-05-25Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEA-S Medication Solutions3ed913ba-f0c0-4ba5-9440-73c4374f42262023-05-25Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEBryant Ranch Prepackf24151c8-02cd-4b07-a7fd-796903210aba2023-05-23Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDENCS HealthCare of KY, LLC dba Vangard Labs201e892d-d963-4c6a-b35b-c5780b01f6592022-12-15Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEAphena Pharma Solutions - Tennessee, LLCb869bc45-1ebb-42fb-82c5-603f098357902017-10-19Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDECamber Pharmaceuticals, Inc.0d4a4ef9-0944-452c-b014-bd822bfb9dd92017-08-14Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDETeva Pharmaceuticals USA, Inc.8a95cbdb-0601-47a5-9b3a-0c3b0629ceb92017-02-28Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE

Reported adverse events (FAERS/openFDA)#

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