FDA.reportPublic FDA data

Application 073637

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIROXICAMPIROXICAMCAPSULE;ORAL10MGNoNo

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
A073637-001PIROXICAMPIROXICAM10MGCAPSULE / ORAL1994-01-28

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 UTC2022-10A073637-001PIROXICAM10MGCAPSULE / ORAL1994-01-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A073637-001PIROXICAM10MGCAPSULE / ORAL1994-01-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A073637-001PIROXICAM10MGCAPSULE / ORAL1994-01-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A073637-001PIROXICAM10MGCAPSULE / ORAL1994-01-28a50c72e98297…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PiroxicamPIROXICAMTeva Pharmaceuticals USA, Inc.f1123fe1-b79c-430b-8548-08cd6e5184822026-08-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMPD-Rx Pharmaceuticals, Inc.923a81d7-78e7-48e9-901d-e3ce3539aba32026-07-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PIROXICAMPIROXICAMBryant Ranch Prepack8b8eb243-0efb-4777-b627-b7ae042f88232026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PIROXICAM
generic name: PIROXICAM
PIROXICAMPIROXICAMMicro Labs Limiteda6335245-7e04-46b9-a505-f47647781e192026-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PIROXICAM
generic name: PIROXICAM
PiroxicamPIROXICAMUnichem Pharmaceuticals (USA), Inc.69631088-2645-4cc9-9c64-a36111ab5d212026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMAvKARE1ea6042e-0090-df18-e063-6394a90a0a0a2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMStrides Pharma Science Limited6039e036-c0aa-4249-af50-115f49ad758a2025-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMDirect_Rxfa56b439-893d-003e-e053-6294a90a865b2025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepack99351f77-46b8-4741-9193-1a6d6a7b0b182024-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepackd9684cb2-76f3-4c1b-b9e5-1f8fe55f36952024-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepack1cd10ca2-f0a5-4b3a-bc5f-e25aba1f903c2024-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepack7ee820e4-a479-4b7d-8730-101ac1f8015c2024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepack7f5ea9e8-3942-4e84-b237-c38517a97a8e2023-10-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepackbf53d94d-9808-44c0-a01b-a08975bc6e212023-10-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PiroxicamPIROXICAMBryant Ranch Prepack0373da3a-7779-4e26-87f1-cd346018282c2023-10-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM
PIROXICAMPIROXICAMProficient Rx LPb48a1615-23b5-4db7-bb96-cec551d227f62022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: PIROXICAM
generic name: PIROXICAM
PiroxicamPIROXICAMProficient Rx LP23972bf0-e5b8-4f4b-97d0-caa05d6b061c2019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Piroxicam
generic name: PIROXICAM

Reported adverse events (FAERS/openFDA)#

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