FDA.reportPublic FDA data

Application 071702

Type
ANDA
Sponsor
QUANTUM PHARMICS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMTABLET;ORAL15MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A071702-001CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL1987-10-26

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A071702-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL1987-10-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071702-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL1987-10-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071702-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL1987-10-26cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A071702-001CLORAZEPATE DIPOTASSIUM15MGTABLET / ORAL1987-10-26a50c72e98297…

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMApotex Corp.6e07efe5-29b6-6d1e-661a-f696c4b17f432026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMClinical Solutions Wholesale, LLC11b72861-64c9-4cdc-9289-c7fa9ea23bf62026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMSun Pharmaceutical Industries, Inc.499a6989-8912-44b7-b1eb-ee8f85ae378f2026-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC919cbd07-f587-4005-acff-26213dd1d1fb2026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLORAZEPATE DIPOTASSIUM
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC40074ed8-0799-e3e0-e063-6394a90ad2002025-09-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMANI Pharmaceuticals, Inc.a4b80e69-b7c7-471a-8ce8-4e992808c6692025-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2d592a27-f4cf-008a-e063-6394a90a26292025-02-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMCoupler LLC2ccaf945-0369-3129-e063-6394a90a27402025-01-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
Clorazepate DipotassiumCLORAZEPATE DIPOTASSIUMNORTHSTAR RX LLCfb5c9e98-02b2-4c36-b436-25b58fe3c7d52024-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Clorazepate Dipotassium
generic name: CLORAZEPATE DIPOTASSIUM
CLORAZEPATE DIPOTASSIUMCLORAZEPATE DIPOTASSIUMAurolife Pharma LLC69451c35-dd9a-4690-8d5e-4dcfa88376202024-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CLORAZEPATE DIPOTASSIUM
generic name: CLORAZEPATE DIPOTASSIUM

Reported adverse events (FAERS/openFDA)#

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