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

NDC Listings For This Application#

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 PharmaNDACurrent
42195-308Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-308Nalfonfenoprofen calciumXspire PharmaNDACurrent
42195-308Nalfonfenoprofen calciumXspire Pharma, LlcNDACurrent
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