Fenoprofen Oral Capsule

Brand(s)
Nalfon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Xspire Pharma (2015-08-11)
Oldest Current Product
2012-08-27
License(s)
NDA
RxNORM
ORAL CAPSULE\FENOPROFEN
FDAOB
ORAL\CAPSULE\FENOPROFEN CALCIUM
SPL Active
ORAL\CAPSULE\FENOPROFEN CALCIUM
SPL Moiety
ORAL\CAPSULE\FENOPROFEN

product(s) by strength(s)

fenoprofen 200 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1421950600NalfonNDAXspire Pharma2012-08-27FENOPROFEN CALCIUMORALCAPSULENDA017604dfc2ab1e-0d75-4eff-9489-2afb51b02702

fenoprofen 400 mg oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1421950100NDAXspire Pharma2015-08-05FENOPROFEN CALCIUMORALCAPSULENDA017604ef59e72f-6218-4f42-8f00-d10a6a14223a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1458650819NDAMedsource Pharmaceuticals2014-07-14FENOPROFEN CALCIUMORALCAPSULE762181215NDA0176042086f746-f91b-1af1-e054-00144ff88e88
2636295388NDABryant Ranch Prepack2014-07-14FENOPROFEN CALCIUMORALCAPSULE762181215NDA017604e18dcccf-bcf2-45d4-b1fe-45729c926854
3687889374NDAPreferred Pharmaceuticals, Inc.2014-08-20FENOPROFEN CALCIUMORALCAPSULE762181215NDA017604490c0e17-0df1-46e1-9666-436a7613e499

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA071738FENOPROFEN CALCIUMTrueQUANTUM PHARMICS LTD1988-08-17ANDA071738_001
2ANDA072214FENOPROFEN CALCIUMTrueQUANTUM PHARMICS LTD1988-08-17ANDA072214_001
3ANDA072293FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1988-08-17ANDA072293_001
4ANDA072294FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1988-08-17ANDA072294_001
5ANDA072307FENOPROFEN CALCIUMTrueAMERICAN THERAPEUTICS INC1988-08-22ANDA072307_001
6ANDA072308FENOPROFEN CALCIUMTrueAMERICAN THERAPEUTICS INC1988-08-22ANDA072308_001
7ANDA072355FENOPROFEN CALCIUMTrueHALSEY DRUG CO INC1988-08-17ANDA072355_001
8ANDA072356FENOPROFEN CALCIUMTrueHALSEY DRUG CO INC1988-08-17ANDA072356_001
9ANDA072394FENOPROFEN CALCIUMTrueSANDOZ INC1988-10-17ANDA072394_001
10ANDA072395FENOPROFEN CALCIUMTrueSANDOZ INC1988-10-17ANDA072395_001
11ANDA072437FENOPROFEN CALCIUMTruePAR PHARMACEUTICAL INC1988-08-22ANDA072437_001
12ANDA072438FENOPROFEN CALCIUMTruePAR PHARMACEUTICAL INC1988-08-22ANDA072438_001
13ANDA072472FENOPROFEN CALCIUMTrueWARNER CHILCOTT DIV WARNER LAMBERT CO1991-04-30ANDA072472_001
14ANDA072946FENOPROFEN CALCIUMTrueWARNER CHILCOTT DIV WARNER LAMBERT CO1991-04-30ANDA072946_001
15ANDA072981FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1991-08-19ANDA072981_001
16ANDA072982FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1991-08-19ANDA072982_001
17NDA017604NALFONXSPIRE LLCNDA017604_002, NDA017604_003, NDA017604_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA071738_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1988-08-17FENOPROFEN CALCIUM
2ANDA072214_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1988-08-17FENOPROFEN CALCIUM
3ANDA072293_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1988-08-17FENOPROFEN CALCIUM
4ANDA072294_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1988-08-17FENOPROFEN CALCIUM
5ANDA072307_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1988-08-22FENOPROFEN CALCIUM
6ANDA072308_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1988-08-22FENOPROFEN CALCIUM
7ANDA072355_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1988-08-17FENOPROFEN CALCIUM
8ANDA072356_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1988-08-17FENOPROFEN CALCIUM
9ANDA072394_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1988-10-17FENOPROFEN CALCIUM
10ANDA072395_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1988-10-17FENOPROFEN CALCIUM
11ANDA072437_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1988-08-22FENOPROFEN CALCIUM
12ANDA072438_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1988-08-22FENOPROFEN CALCIUM
13ANDA072472_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1991-04-30FENOPROFEN CALCIUM
14ANDA072946_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1991-04-30FENOPROFEN CALCIUM
15ANDA072981_001discontinuedFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULEFalse1991-08-19FENOPROFEN CALCIUM
16ANDA072982_001discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalse1991-08-19FENOPROFEN CALCIUM
17NDA017604_002discontinuedFENOPROFEN CALCIUM (EQ 300MG BASE)ORALCAPSULEFalseNALFON
18NDA017604_003RXFENOPROFEN CALCIUM (EQ 200MG BASE)ORALCAPSULETrueNALFON
19NDA017604_004RXFENOPROFEN CALCIUM (EQ 400MG BASE)ORALCAPSULEFalse2009-07-21NALFON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12086f746-f91b-1af1-e054-00144ff88e88 (view SPL)Fenoprofen Calcium Capsules, USP 200 mg and 400 mgprescriptionHuman PrescriptionMedsource Pharmaceuticalsrepack2015-09-241458650819
2490c0e17-0df1-46e1-9666-436a7613e499 (view SPL)Fenoprofen Calcium Capsules, USP 200 mg and 400 mgprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2014-08-201687889374
3dfc2ab1e-0d75-4eff-9489-2afb51b02702 (view SPL)NALFON (fenoprofen calcium capsules, USP) 200 mg and 400 mgprescriptionHuman PrescriptionXspire PharmaMANUFACTURE2012-09-051421950600, 421950308
4e18dcccf-bcf2-45d4-b1fe-45729c926854 (view SPL)Fenoprofen Calcium Capsules, USP200 mg and 400 mgprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-09-111000636295388
5ef59e72f-6218-4f42-8f00-d10a6a14223a (view SPL)fenoprofen calcium capsulesprescriptionHuman PrescriptionXspire Pharmamanufacture2015-08-111421950100

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII