Phentermine Disintegrating Oral Tablet

Brand(s)
Suprenza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akrimax Pharmaceuticals, Llc (2013-06-14)
Oldest Current Product
2012-12-14
License(s)
NDA
RxNORM
DISINTEGRATING ORAL TABLET\PHENTERMINE
FDAOB
ORAL\TABLET, ORALLY DISINTEGRATING\PHENTERMINE HYDROCHLORIDE
SPL Active
ORAL\TABLET, ORALLY DISINTEGRATING\PHENTERMINE HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, ORALLY DISINTEGRATING\PHENTERMINE

product(s) by strength(s)

phentermine hydrochloride 15 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900720SuprenzaNDAAkrimax Pharmaceuticals, Llc2012-12-14PHENTERMINE HYDROCHLORIDEORALTABLET, ORALLY DISINTEGRATINGNDA202088b961e6cc-4956-405f-9e53-b55604be23f6

phentermine hydrochloride 30 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900721SuprenzaNDAAkrimax Pharmaceuticals, Llc2012-12-14PHENTERMINE HYDROCHLORIDEORALTABLET, ORALLY DISINTEGRATINGNDA202088b961e6cc-4956-405f-9e53-b55604be23f6

phentermine hydrochloride 37.5 mg disintegrating oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1240900722SuprenzaNDAAkrimax Pharmaceuticals, Llc2012-12-14PHENTERMINE HYDROCHLORIDEORALTABLET, ORALLY DISINTEGRATINGNDA202088b961e6cc-4956-405f-9e53-b55604be23f6

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA202088SUPRENZACITIUS PHARMACEUTICALS LLC2011-06-13p8440170, SUBSTANCE
p6149938, WITH DRY HANDS, SUBSTANCE
NDA202088_001, NDA202088_002, NDA202088_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202088_001RXPHENTERMINE HYDROCHLORIDE (15MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2011-06-13SUPRENZA
2NDA202088_002RXPHENTERMINE HYDROCHLORIDE (30MG)ORALTABLET, ORALLY DISINTEGRATINGFalse2011-06-13SUPRENZA
3NDA202088_003RXPHENTERMINE HYDROCHLORIDE (37.5MG)ORALTABLET, ORALLY DISINTEGRATINGTrue2012-03-27SUPRENZA

patent(s)

#idexpiration dateapplication(s)
1p6149938 (view patent)2018-07-23NDA202088
2p8440170 (view patent)2029-03-14NDA202088

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1b961e6cc-4956-405f-9e53-b55604be23f6 (view SPL)These highlights do not include all the information needed to use SUPRENZA safely and effectively. See full prescribing information for SUPRENZA SUPRENZATM (phentermine hydrochloride) orally disintegrating tablet C IVInitial U.S. Approval: 1959prescriptionHuman PrescriptionAkrimax Pharmaceuticals, LlcAPI MANUFACTURE, MANUFACTURE2013-06-1415240900720, 240900721, 240900722

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