Fenoprofen Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Pharmaceuticals Inc. (2015-07-20)
Oldest Current Product
2009-11-23
License(s)
ANDA
RxNORM
ORAL TABLET\FENOPROFEN
FDAOB
ORAL\TABLET\FENOPROFEN CALCIUM
SPL Active
ORAL\TABLET, FILM COATED\FENOPROFEN CALCIUM
SPL Moiety
ORAL\TABLET, FILM COATED\FENOPROFEN

product(s) by strength(s)

fenoprofen 600 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003780471ANDAMylan Pharmaceuticals Inc.2012-11-14FENOPROFEN CALCIUMORALTABLET, FILM COATEDANDA072267f90becaa-a4f3-44aa-ac8c-c69935c5ddb2

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1552890334ANDAPd-Rx Pharmaceuticals, Inc.2009-11-23FENOPROFEN CALCIUMORALTABLET, FILM COATED003780471ANDA07226763ef1e04-7065-46b9-82c1-c2d0c76880a8

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA072165FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1988-08-17ANDA072165_001
2ANDA072194FENOPROFEN CALCIUMTrueQUANTUM PHARMICS LTD1988-08-17ANDA072194_001
3ANDA072267FENOPROFEN CALCIUMMYLAN PHARMACEUTICALS INC1988-08-17ANDA072267_001
4ANDA072274FENOPROFEN CALCIUMTrueACTAVIS ELIZABETH LLC1988-05-02ANDA072274_001
5ANDA072309FENOPROFEN CALCIUMTrueAMERICAN THERAPEUTICS INC1988-08-17ANDA072309_001
6ANDA072326FENOPROFEN CALCIUMTrueDAVA PHARMACEUTICALS INC1988-08-17ANDA072326_001
7ANDA072357FENOPROFEN CALCIUMTrueHALSEY DRUG CO INC1988-08-17ANDA072357_001
8ANDA072362FENOPROFEN CALCIUMTrueUSL PHARMA INC1988-08-17ANDA072362_001
9ANDA072396FENOPROFEN CALCIUMTrueSANDOZ INC1988-10-17ANDA072396_001
10ANDA072407FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1988-08-17ANDA072407_001
11ANDA072429FENOPROFEN CALCIUMTruePAR PHARMACEUTICAL INC1988-08-17ANDA072429_001
12ANDA072557FENOPROFEN CALCIUMTrueIVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA1988-08-29ANDA072557_001
13ANDA072602FENOPROFEN CALCIUMTrueWATSON LABORATORIES INC1988-10-11ANDA072602_001
14ANDA072902FENOPROFEN CALCIUMTrueMUTUAL PHARMACEUTICAL CO INC1990-12-21ANDA072902_001
15NDA017710NALFONTrueDISTA PRODUCTS CO DIV ELI LILLY AND CONDA017710_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA072165_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
2ANDA072194_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
3ANDA072267_001RXFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETTrue1988-08-17FENOPROFEN CALCIUM
4ANDA072274_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-05-02FENOPROFEN CALCIUM
5ANDA072309_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
6ANDA072326_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
7ANDA072357_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
8ANDA072362_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
9ANDA072396_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-10-17FENOPROFEN CALCIUM
10ANDA072407_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
11ANDA072429_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-17FENOPROFEN CALCIUM
12ANDA072557_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-08-29FENOPROFEN CALCIUM
13ANDA072602_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1988-10-11FENOPROFEN CALCIUM
14ANDA072902_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalse1990-12-21FENOPROFEN CALCIUM
15NDA017710_001discontinuedFENOPROFEN CALCIUM (EQ 600MG BASE)ORALTABLETFalseNALFON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
163ef1e04-7065-46b9-82c1-c2d0c76880a8 (view SPL)prescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2009-04-096552890334
2f90becaa-a4f3-44aa-ac8c-c69935c5ddb2 (view SPL)prescriptionHuman PrescriptionMylan Pharmaceuticals Inc.2015-07-208003780471

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