FDA.reportPublic FDA data

Application 017604

Type
NDA
Sponsor
XSPIRE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002NALFONFENOPROFEN CALCIUMCAPSULE;ORALEQ 300MG BASENoNo
003NALFONFENOPROFEN CALCIUMCAPSULE;ORALEQ 200MG BASEYesNo
004NALFONFENOPROFEN CALCIUMCAPSULE;ORALEQ 400MG BASEYesYes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017604-002NALFONFENOPROFEN CALCIUMEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982
N017604-003NALFONFENOPROFEN CALCIUMEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982
N017604-004NALFONFENOPROFEN CALCIUMEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2009-07-21

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N017604-002NALFONEQ 300MG BASECAPSULE / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N017604-004NALFONEQ 400MG BASECAPSULE / ORALABRLD, RS2009-07-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017604-002NALFONEQ 300MG BASECAPSULE / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N017604-004NALFONEQ 400MG BASECAPSULE / ORALABRLD, RS2009-07-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017604-002NALFONEQ 300MG BASECAPSULE / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017604-003NALFONEQ 200MG BASECAPSULE / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017604-004NALFONEQ 400MG BASECAPSULE / ORALRLD, RS2009-07-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017604-002NALFONEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017604-003NALFONEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017604-004NALFONEQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE / ORALRLD2009-07-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05N017604-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N017604-004AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017604-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017604-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017604-003AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02N017604-004AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017604-003AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N017604-004AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017604-003AB1a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017604-004AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017604-003AB19b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017604-004AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017604-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017604-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017604-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017604-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017604-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017604-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017604-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017604-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017604-004AB1e64feba35796…

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 · 1 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 reactionsExact identifier
ndc (product): 0276-0503
ndc (product): 0276-0501
ndc (product): 0276-0502

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0276-0501Fenoprofen CalciumFenoprofen CalciumMisemer Pharmaceuticals, Inc.NDACurrent
0276-0501Fenoprofen CalciumFenoprofen CalciumMisemer Pharmaceuticals, Inc.NDACurrent
0276-0502Fenoprofen CalciumFenoprofen CalciumMisemer Pharmaceuticals, Inc.NDACurrent
0276-0503Fenoprofen CalciumFenoprofen CalciumMisemer Pharmaceuticals, Inc.NDACurrent
15014-400Fenoprofen CalciumFenoprofen CalciumGentex PharmaNDA AUTHORIZED GENERICCurrent
15014-400Fenoprofen Calciumfenoprofen calciumGentex PharmaNDA AUTHORIZED GENERICCurrent
15014-400Fenoprofen Calciumfenoprofen calciumGentex PharmaNDA AUTHORIZED GENERICCurrent
15014-400Fenoprofen Calciumfenoprofen calciumGentex PharmaNDA AUTHORIZED GENERICCurrent
42195-100Fenoprofen Calciumfenoprofen calciumXspire PharmaNDA AUTHORIZED GENERICCurrent
42195-100Fenoprofen Calciumfenoprofen calciumXspire Pharma, LlcNDA AUTHORIZED GENERICCurrent
42195-100Fenoprofen Calciumfenoprofen calciumXspire PharmaNDA AUTHORIZED GENERICCurrent
42195-100Fenoprofen Calciumfenoprofen calciumXspire PharmaNDA AUTHORIZED GENERICCurrent
42195-308Nalfonfenoprofen calciumXspire Pharma, LlcNDACurrent
42195-308Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-308Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-308Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-600Nalfonfenoprofen calciumXspire Pharma, LlcNDACurrent
42195-600Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-600Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-600Nalfonfenoprofen calciumXspire PharmaNDACurrent
50090-3572Fenoprofen Calciumfenoprofen calciumA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
50090-3572Fenoprofen Calciumfenoprofen calciumA-S Medication SolutionsNDA AUTHORIZED GENERICCurrent
53217-169Fenoprofen Calciumfenoprofen calciumAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
54288-131FENOPROFEN CALCIUMFENOPROFEN CALCIUMBPI Labs LLCNDACurrent
54288-132FENOPROFEN CALCIUMFENOPROFEN CALCIUMBPI Labs LLCNDACurrent
55700-853Nalfonfenoprofen calciumQuality Care Products, LLCNDACurrent
55700-853Nalfonfenoprofen calciumQuality Care Products, LLCNDACurrent
62250-691FENOPROFENFENOPROFEN CALCIUMBelcher Pharmaceuticals,LLCNDACurrent
63187-706Nalfonfenoprofen calciumProficient Rx LPNDACurrent
63187-706Nalfonfenoprofen calciumProficient Rx LPNDACurrent
63187-706Nalfonfenoprofen calciumProficient Rx LPNDACurrent
63187-706Nalfonfenoprofen calciumProficient Rx LPNDACurrent
63629-5388FenoprofenfenoprofenBryant Ranch PrepackNDACurrent
63629-7515Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
63629-7515Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
63629-7515Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
63629-7515Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
63629-8016Fenoprofen Calciumfenoprofen calciumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8016Fenoprofen Calciumfenoprofen calciumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
63629-8016Fenoprofen Calciumfenoprofen calciumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
69101-400Fenoprofen Calciumfenoprofen calciumBurke Therapeutics, LLCNDACurrent
69101-400Fenoprofen Calciumfenoprofen calciumBurke Therapeutics, LLCNDACurrent
69336-113FENORTHOFENORTHOSterling Knight Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69336-113FENORTHOFENORTHOSterling Knight Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
69336-124FENOPROFEN CALCIUMFENOPROFEN CALCIUMSterling Knight PharmaceuticalsNDACurrent
69336-124FENOPROFEN CALCIUMFENOPROFEN CALCIUMSterling Knight PharmaceuticalsNDACurrent
71335-0307Fenoprofen Calciumfenoprofen calciumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0307Fenoprofen Calciumfenoprofen calciumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0307Fenoprofen Calciumfenoprofen calciumBryant Ranch PrepackNDA AUTHORIZED GENERICCurrent
71335-0805Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
71335-0805Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
71335-0805Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
71335-1302Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent
71335-1302Nalfonfenoprofen calciumBryant Ranch PrepackNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80366SUPPL 2024-11-25
80365SUPPL 2024-11-25
80339SUPPL 2024-11-25
67332SUPPL2021-05-03
67224SUPPL2021-04-29
13868SUPPL2016-05-11
11048SUPPL2016-05-11
43596ORIG2009-11-19
11047SUPPL2009-07-24
665SUPPL2009-07-23
11046SUPPL2007-08-14
664SUPPL2007-08-14
13867SUPPL2006-01-20
11045SUPPL2006-01-20