Application 090613

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TORSEMIDETORSEMIDETABLET;ORAL5MGNoNo
002TORSEMIDETORSEMIDETABLET;ORAL10MGNoNo
003TORSEMIDETORSEMIDETABLET;ORAL20MGNoNo
004TORSEMIDETORSEMIDETABLET;ORAL100MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090613-001TORSEMIDETORSEMIDE5MGTABLET / ORAL2011-03-22
A090613-002TORSEMIDETORSEMIDE10MGTABLET / ORAL2011-03-22
A090613-003TORSEMIDETORSEMIDE20MGTABLET / ORAL2011-03-22
A090613-004TORSEMIDETORSEMIDE100MGTABLET / ORAL2011-03-22

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 22:54:322026-06A090613-001TORSEMIDE5MGTABLET / ORAL2011-03-22a50c72e98297…
2026-08-01 22:54:322026-06A090613-002TORSEMIDE10MGTABLET / ORAL2011-03-22a50c72e98297…
2026-08-01 22:54:322026-06A090613-003TORSEMIDE20MGTABLET / ORAL2011-03-22a50c72e98297…
2026-08-01 22:54:322026-06A090613-004TORSEMIDE100MGTABLET / ORAL2011-03-22a50c72e98297…

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 2 · 33 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TorsemideTORSEMIDEREMEDYREPACK INC.1c755d94-b846-4336-a968-aa1b92dc0ac02026-07-21Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEMajor Pharmaceuticals09305350-e317-419c-96f5-aa8fbeb4044d2026-03-26Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEAvKARE7fc14338-92e4-cf57-a3e8-ef64d8d1026c2026-02-11Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
SOAANZTORSEMIDESarfez Pharmaceuticals Inc05eaa163-b6e9-438a-85f8-6a60e743d4602026-01-09Name fallback
generic name: TORSEMIDE
TorsemideTORSEMIDEAvPAKf1439b9c-c01c-a6d4-594b-d92b8e0af26e2025-12-31Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEChartwell RX, LLCa3d68763-95e0-4ad6-89c2-c4b1c0b439482025-12-10Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDERedpharm Drug44f2f06d-7bc4-5239-e063-6394a90aac5e2025-12-02Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEBryant Ranch Prepack0b3cfce4-61fc-42ba-9ea7-51f81ea014f72025-10-22Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEBryant Ranch Prepacke707eda7-4bde-4944-ae19-1b4fa35b6a3c2025-10-22Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEREMEDYREPACK INC.26a3af16-39fc-482d-8a8e-9473af4b0e3f2025-09-26Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEBryant Ranch Prepackda8f2bf5-741c-45f6-b873-31a9fda2f8802025-06-26Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TORSEMIDETORSEMIDEDirect_Rx91d45625-5ba6-b50f-e053-2a95a90ac3142025-01-17Warnings, Adverse reactionsName fallback
brand name: TORSEMIDE
generic name: TORSEMIDE
TorsemideTORSEMIDEBryant Ranch Prepack16dfba29-4c26-45e7-ac7d-b2ec2058e2bb2024-11-04Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEA-S Medication Solutionse58a7d1c-6584-44c3-98ce-a3e9b64e9c822024-10-31Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEAmerican Health Packagingaaabbaca-ba6f-42d5-980d-71135c7c80ea2024-10-25Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEGolden State Medical Supply, Inc.2411e6f8-4fc3-f986-e063-6294a90a055a2024-10-09Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEA-S Medication Solutions05c8a6ee-9517-453f-8dd6-7e5ca83c5a682024-10-01Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDENCS HealthCare of KY, LLC dba Vangard Labs99b537f3-1fbf-48b7-ac3e-0a43e6aab3132024-09-30Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEXLCare Pharmaceuticals Inc.234ff9d7-a02e-417f-a1f9-94038783cc772024-09-10Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE
TorsemideTORSEMIDEBryant Ranch Prepack13d851b6-3355-4541-93e8-73cdaf0f13d12024-07-16Warnings, Adverse reactionsName fallback
brand name: Torsemide
generic name: TORSEMIDE