phendimetrazine Extended Release Oral Capsule

Brand(s)
Bontril
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eon Labs, Inc. (2012-02-22)
Oldest Current Product
1977-09-06
License(s)
NDA, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\PHENDIMETRAZINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\PHENDIMETRAZINE TARTRATE
SPL Active
ORAL\CAPSULE, EXTENDED RELEASE\PHENDIMETRAZINE TARTRATE
ORAL\CAPSULE\PHENDIMETRAZINE TARTRATE
SPL Moiety
ORAL\CAPSULE, EXTENDED RELEASE\PHENDIMETRAZINE
ORAL\CAPSULE\PHENDIMETRAZINE

product(s) by strength(s)

24 hr phendimetrazine tartrate 105 mg extended release oral capsule

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001855254NDAEon Labs, Inc.1977-09-06PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASENDA018074fc4a052c-29ff-428b-bdf1-bb079f10c0bc

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340782BontrilANDAApotheca, Inc2010-04-08PHENDIMETRAZINE TARTRATEORALCAPSULE001870498ANDA088021c4adaaef-cb23-4e29-8645-347578beb60a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1126340910NDAApotheca, Inc2010-01-10PHENDIMETRAZINE TARTRATEORALCAPSULE001855254NDA0180745803a3c0-7434-40f3-af5e-cf33b3e2c448
2332610390NDAAidarex Pharmaceuticals Llc1977-09-06PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASE001855254NDA01807479c40fc0-bfd0-4a35-bb3f-5193a9930f7c
3500900338NDAA-S Medication Solutions Llc1977-09-06PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASE001855254NDA0180741aa3fdcb-b107-406c-bbe1-78da87852d77
4545692198NDAA-S Medication Solutions Llc1977-09-06PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASE001855254NDA0180740e188d37-adea-40d7-a7cb-1344a80d4260
5548683071NDAPhysicians Total Care, Inc.2009-05-11PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASE001855254NDA01807467e2f269-b73d-4ff5-8177-ecf79536648c
6552890302NDAPd-Rx Pharmaceuticals, Inc.1977-09-06PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASE001855254NDA01807422715e86-f3f7-4b17-a7ad-7c16b955b1c4
7636293051NDABryant Ranch Prepack1977-09-06PHENDIMETRAZINE TARTRATEORALCAPSULE, EXTENDED RELEASE001855254NDA018074675e6738-a39c-209d-0f05-aa120f0a0695

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA087214PHENDIMETRAZINE TARTRATETrueDM GRAHAM LABORATORIES INC1982-05-26ANDA087214_001
2ANDA087371X-TROZINE L.A.TrueSHIRE RICHWOOD INC1982-08-24ANDA087371_001
3ANDA087378PHENDIMETRAZINE TARTRATETrueSANDOZ INCANDA087378_001
4ANDA087487MELFIAT-105TrueNUMARK LABORATORIES INC1982-10-13ANDA087487_001
5ANDA088020PHENDIMETRAZINE TARTRATETrueDM GRAHAM LABORATORIES INC1982-08-16ANDA088020_001
6ANDA088021BONTRILTrueVALEANT PHARMACEUTICALS INTERNATIONAL1982-09-21ANDA088021_001
7ANDA088024SPRX-105TrueNUMARK LABORATORIES INC1982-12-22ANDA088024_001
8ANDA088028PHENDIMETRAZINE TARTRATETrueDM GRAHAM LABORATORIES INC1982-08-16ANDA088028_001
9ANDA088062PHENDIMETRAZINE TARTRATETrueDM GRAHAM LABORATORIES INC1982-09-13ANDA088062_001
10ANDA088063PHENDIMETRAZINE TARTRATETrueDM GRAHAM LABORATORIES INC1982-09-10ANDA088063_001
11ANDA088111PHENDIMETRAZINE TARTRATETrueDM GRAHAM LABORATORIES INC1982-10-18ANDA088111_001
12NDA018074PHENDIMETRAZINE TARTRATESANDOZ INCNDA018074_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA087214_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-05-26PHENDIMETRAZINE TARTRATE
2ANDA087371_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-08-24X-TROZINE L.A.
3ANDA087378_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalsePHENDIMETRAZINE TARTRATE
4ANDA087487_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-10-13MELFIAT-105
5ANDA088020_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-08-16PHENDIMETRAZINE TARTRATE
6ANDA088021_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-09-21BONTRIL
7ANDA088024_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-12-22SPRX-105
8ANDA088028_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-08-16PHENDIMETRAZINE TARTRATE
9ANDA088062_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-09-13PHENDIMETRAZINE TARTRATE
10ANDA088063_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-09-10PHENDIMETRAZINE TARTRATE
11ANDA088111_001discontinuedPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASEFalse1982-10-18PHENDIMETRAZINE TARTRATE
12NDA018074_001RXPHENDIMETRAZINE TARTRATE (105MG)ORALCAPSULE, EXTENDED RELEASETruePHENDIMETRAZINE TARTRATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10e188d37-adea-40d7-a7cb-1344a80d4260 (view SPL)Phendimetrazine TartrateExtended-release Capsules CIIIprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-04-271545692198
21aa3fdcb-b107-406c-bbe1-78da87852d77 (view SPL)Phendimetrazine TartrateExtended-release Capsules CIIIprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2014-12-151500900338
322715e86-f3f7-4b17-a7ad-7c16b955b1c4 (view SPL)Phendimetrazine TartrateExtended-release Capsules CIIIprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-02-228552890302
45803a3c0-7434-40f3-af5e-cf33b3e2c448 (view SPL)Phendimetrazine Tartrate 105mg ER Capsule CIII Rx OnlyprescriptionHuman PrescriptionApotheca, Inc2010-04-082126340910
5675e6738-a39c-209d-0f05-aa120f0a0695 (view SPL)PhendimetrazineprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-122636293051
667e2f269-b73d-4ff5-8177-ecf79536648c (view SPL)Phendimetrazine TartrateExtended-release Capsules CIIIprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-04-103548683071
779c40fc0-bfd0-4a35-bb3f-5193a9930f7c (view SPL)Phendimetrazine TartrateExtended-release Capsules CIIIprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-231332610390
8c4adaaef-cb23-4e29-8645-347578beb60a (view SPL)Bontril (phendimetrazine tartrate) Capsule SR 105MG USP Rx Only Clll Trademark of Valeant PharmaceuticalprescriptionHuman PrescriptionApotheca, Inc2010-04-081126340782
9fc4a052c-29ff-428b-bdf1-bb079f10c0bc (view SPL)Phendimetrazine TartrateExtended-release Capsules CIIIprescriptionHuman PrescriptionEon Labs, Inc.2012-02-227001855254

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