Phentermine Extended Release Oral Capsule

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Lannett Company, Inc. (2013-01-31)
Oldest Current Product
2011-07-28
License(s)
ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\PHENTERMINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\PHENTERMINE RESIN COMPLEX
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\PHENTERMINE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\PHENTERMINE

product(s) by strength(s)

phentermine resin 15 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271398ANDALannett Company, Inc.2011-07-28PHENTERMINEORALCAPSULE, EXTENDED RELEASEANDA0408727ca86c66-409b-4852-8631-c3ada6e60738

phentermine resin 30 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005271366ANDALannett Company, Inc.2011-07-28PHENTERMINEORALCAPSULE, EXTENDED RELEASEANDA0408727ca86c66-409b-4852-8631-c3ada6e60738

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040872PHENTERMINE RESIN COMPLEXLANNETT HOLDINGS INC2011-07-28ANDA040872_001, ANDA040872_002
2ANDA089120PHENTERMINE RESIN 30TrueQUANTUM PHARMICS LTD1988-02-04ANDA089120_001
3NDA011613IONAMINTrueUCB INCNDA011613_002, NDA011613_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA040872_001RXPHENTERMINE RESIN COMPLEX (EQ 15MG BASE)ORALCAPSULE, EXTENDED RELEASETrue2011-07-28PHENTERMINE RESIN COMPLEX
2ANDA040872_002RXPHENTERMINE RESIN COMPLEX (EQ 30MG BASE)ORALCAPSULE, EXTENDED RELEASETrue2011-07-28PHENTERMINE RESIN COMPLEX
3ANDA089120_001discontinuedPHENTERMINE RESIN COMPLEX (EQ 30MG BASE)ORALCAPSULE, EXTENDED RELEASEFalse1988-02-04PHENTERMINE RESIN 30
4NDA011613_002discontinuedPHENTERMINE RESIN COMPLEX (EQ 30MG BASE)ORALCAPSULE, EXTENDED RELEASEFalseIONAMIN
5NDA011613_004discontinuedPHENTERMINE RESIN COMPLEX (EQ 15MG BASE)ORALCAPSULE, EXTENDED RELEASEFalseIONAMIN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
17ca86c66-409b-4852-8631-c3ada6e60738 (view SPL)These highlights do not include all the information needed to use phentermine resin extended-release capsules safely and effectively. See full prescribing information for phentermine resin extended-release capsules. PHENTERMINE Resin Extended-Release Capsules CIV Initial U.S. Approval: 1959prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-01-319005271366, 005271398

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