FDA.reportPublic FDA data

Application 072437

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FENOPROFEN CALCIUMFENOPROFEN CALCIUMCAPSULE;ORALEQ 200MG BASENoNo

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

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
A072437-001FENOPROFEN CALCIUMFENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL1988-08-22

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A072437-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL1988-08-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A072437-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL1988-08-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A072437-001FENOPROFEN CALCIUMEQ 200MG BASECAPSULE / ORAL1988-08-22a50c72e98297…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fenoprofen CalciumFENOPROFEN CALCIUMMisemer Pharmaceuticals, Inc.d33ad329-1ca6-ac2e-e053-2995a90a15c52026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fenoprofen Calcium
generic name: FENOPROFEN CALCIUM
Fenoprofen CalciumFENOPROFEN CALCIUMCoral Way Pharma, LLC56b07659-1fd8-4c3e-e063-6294a90a89082026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fenoprofen Calcium
generic name: FENOPROFEN CALCIUM
Fenoprofen calciumFENOPROFEN CALCIUMAtland Pharmaceuticals, LLCb26c8351-a955-4685-adad-a7233db39d922026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Fenoprofen calcium
generic name: FENOPROFEN CALCIUM
FENOPRON TMFENOPROFEN CALCIUMGalt Pharmaceuticals, LLC2ed1a69a-2375-4cc8-ac2f-1201d7e0b9d02026-02-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: FENOPROFEN CALCIUM
FENOPROFEN CALCIUMFENOPROFEN CALCIUMRising Pharma Holdings, Inc.4aa38cca-9f8f-4ab6-8103-4f1f48801a432025-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FENOPROFEN CALCIUM
generic name: FENOPROFEN CALCIUM
FENOPROFEN CALCIUMFENOPROFEN CALCIUMAtland Pharmaceuticals, LLC3daa336f-2acf-4109-a360-b1d30b192d412024-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FENOPROFEN CALCIUM
generic name: FENOPROFEN CALCIUM
FENOPROFEN CALCIUMFENOPROFEN CALCIUMProficient Rx LP1d438989-6431-4c62-8f24-444475d423a32023-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: FENOPROFEN CALCIUM
generic name: FENOPROFEN CALCIUM

Reported adverse events (FAERS/openFDA)#

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