Acetaminophen / butalbital Oral Capsule

Brand(s)
Phrenilin
Category(s)
prescription
SPL Type(s)
Human Prescription
Oldest Current Product
2004-05-03
License(s)
ANDA
RxNORM
ORAL CAPSULE\ACETAMINOPHEN:BUTALBITAL
FDAOB
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL
SPL Active
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL
SPL Moiety
ORAL\CAPSULE\ACETAMINOPHEN: BUTALBITAL

product(s) by strength(s)

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1001870844PhrenilinANDAValeant Pharmaceuticals North America Llc2004-05-032016-09-30ACETAMINOPHEN, BUTALBITALORALCAPSULEANDA088831a81c62d2-8151-42db-bda7-e08578ac5089

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA088831PHRENILIN FORTETrueVALEANT PHARMACEUTICALS INTERNATIONAL1985-06-19ANDA088831_001
2ANDA088889BANCAPTrueFOREST PHARMACEUTICALS INC1986-01-16ANDA088889_001
3ANDA088991BUCETTrueMALLINCKRODT CHEMICAL INC1985-06-28ANDA088991_001
4ANDA089268TRIAPRINTrueDUNHALL PHARMACEUTICALS INC1987-07-02ANDA089268_001
5ANDA089405TENCONTrueMALLINCKRODT CHEMICAL INC1990-05-15ANDA089405_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA088831_001discontinuedACETAMINOPHEN (650MG), BUTALBITAL (50MG)ORALCAPSULEFalse1985-06-19PHRENILIN FORTE
2ANDA088889_001discontinuedACETAMINOPHEN (325MG), BUTALBITAL (50MG)ORALCAPSULEFalse1986-01-16BANCAP
3ANDA088991_001discontinuedACETAMINOPHEN (650MG), BUTALBITAL (50MG)ORALCAPSULEFalse1985-06-28BUCET
4ANDA089268_001discontinuedBUTALBITAL (50MG), ACETAMINOPHEN (325MG)ORALCAPSULEFalse1987-07-02TRIAPRIN
5ANDA089405_001discontinuedBUTALBITAL (50MG), ACETAMINOPHEN (650MG)ORALCAPSULEFalse1990-05-15TENCON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1a81c62d2-8151-42db-bda7-e08578ac5089 (view SPL)PHRENILIN (Butalbital 50 mg and Acetaminophen 325 mg Tablet)prescriptionHuman PrescriptionValeant Pharmaceuticals North America LlcMANUFACTURE2014-12-2311001870844, 001870842Acetaminophen / butalbital Oral Tablet

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