FDA.reportPublic FDA data

Application 075843

Type
ANDA
Sponsor
ACTAVIS ELIZABETH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXAPROZINOXAPROZINTABLET;ORAL600MGNoNo

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
A075843-001OXAPROZINOXAPROZIN600MGTABLET / ORAL2001-10-03

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 UTC2022-10A075843-001OXAPROZIN600MGTABLET / ORAL2001-10-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075843-001OXAPROZIN600MGTABLET / ORAL2001-10-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075843-001OXAPROZIN600MGTABLET / ORAL2001-10-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075843-001OXAPROZIN600MGTABLET / ORAL2001-10-03a50c72e98297…

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
OxaprozinOXAPROZINST MARY'S MEDICAL PARK PHARMACYe881dca6-004e-1c3e-e053-2a95a90a02ab2026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
OxaprozinOXAPROZINSOLA Pharmaceuticals, LLC450f5941-7f10-42fe-e063-6394a90a48032025-12-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
OxaprozinOXAPROZINProficient Rx LPe3fbea8c-bc0d-4dcd-a14e-a4575dceeea62025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
COXANTOOXAPROZINSOLA Pharmaceuticals, LLC918127f0-9f2a-4edf-a2f7-07c01aa52bb52025-10-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: OXAPROZIN
OxaprozinOXAPROZINDr. Reddy's Laboratories Limitedda457b34-ca08-60df-045b-1ae80d2f7e712025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
OxaprozinOXAPROZINAmneal Pharmaceuticals NY LLCd9b0ca6c-4c53-4f6e-918b-02a8c472a1942024-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
OxaprozinOXAPROZINDirect_Rx284ce161-0a4a-8999-e063-6394a90aa60a2024-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
OXAPROZINOXAPROZINChartwell RX, LLC.db349233-9f09-471c-aeee-f91338d2ffe92024-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: OXAPROZIN
generic name: OXAPROZIN
OxaprozinOXAPROZINBryant Ranch Prepackdcb85e40-3427-4e56-910d-c1b07bb5c0fa2024-09-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN
OxaprozinOXAPROZINBryant Ranch Prepackc157016e-0777-4ad7-89b8-487c47bb74cb2023-10-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Oxaprozin
generic name: OXAPROZIN

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8806ORIG2003-04-15