FDA Orange Book · active-ingredient family
Fenoprofen calcium
Fenoprofen calcium: 2 brands, 32 generics; first approved May 02, 1988; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 32 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
32
Listed patents
0
Presentations
40
Brand (NDA) products
Originator applications
- NALFONRLDPHARMACONDA 017604—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 400MG BASE CAPSULE ORAL Discontinued — - NALFONRLDDISTANDA 017710—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued —
Generic (ANDA) products (32)
Abbreviated applications
- FENOPROFEN CALCIUMRISINGANDA 21447520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE CAPSULE ORAL Rx — EQ 200MG BASE CAPSULE ORAL Rx — EQ 300MG BASE CAPSULE ORAL Rx — - FENOPROFEN CALCIUMMISEMERANDA 21554820233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — EQ 300MG BASE CAPSULE ORAL Discontinued — EQ 400MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABSANDA 0729811991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABSANDA 0729821991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMWARNER CHILCOTTANDA 0729461991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMWARNER CHILCOTTANDA 0724721991
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMSUN PHARM INDUSTRIESANDA 0729021990
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMRISINGANDA 0723941988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMRISINGANDA 0723951988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMRISINGANDA 0723961988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABSANDA 0726021988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMIVAX SUB TEVA PHARMSANDA 0725571988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMAM THERAPANDA 0723071988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMAM THERAPANDA 0723081988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMPAR PHARMANDA 0724371988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMPAR PHARMANDA 0724381988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMHALSEYANDA 0723551988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMHALSEYANDA 0723561988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMQUANTUM PHARMICSANDA 0722141988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMQUANTUM PHARMICSANDA 0717381988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABSANDA 0722941988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABSANDA 0722931988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 300MG BASE CAPSULE ORAL Discontinued — - FENOPROFEN CALCIUMAM THERAPANDA 0723091988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMDAVA PHARMS INCANDA 0723261988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMHALSEYANDA 0723571988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMPHARMACOANDA 0722671988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMQUANTUM PHARMICSANDA 0721941988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMSTRIDES PHARMA INTLANDA 0724291988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMUSL PHARMAANDA 0723621988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABSANDA 0721651988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMWATSON LABS TEVAANDA 0724071988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued — - FENOPROFEN CALCIUMANI PHARMSANDA 0722741988
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MG BASE TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
38 yr 10 mo ago
Most recent approval
2 yr 1 mo ago
Approvals span 1988–2024 across 34 FDA applications.
Brand (NDA) 26%
Generic (ANDA) 3294%
Fenoprofen calcium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

