Amphetamine Oral Tablet

Brand(s)
Evekeo
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Arbor Pharmaceuticals, Inc. (2015-11-11)
Oldest Current Product
2015-02-01
License(s)
ANDA
RxNORM
ORAL TABLET\AMPHETAMINE
FDAOB
ORAL\TABLET\AMPHETAMINE SULFATE
SPL Active
ORAL\TABLET\AMPHETAMINE SULFATE
SPL Moiety
ORAL\TABLET\AMPHETAMINE

product(s) by strength(s)

amphetamine sulfate 10 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1243380021EvekeoANDAArbor Pharmaceuticals, Inc.2015-02-012017-10-11AMPHETAMINE SULFATEORALTABLETANDA200166bb12811f-4cce-4010-aa48-d17c46ca1d3a
2243380026EvekeoANDAArbor Pharmaceuticals, Inc.2015-11-01AMPHETAMINE SULFATEORALTABLETANDA200166f469fb38-0380-4621-9db3-a4f429126156

amphetamine sulfate 5 mg oral tablet

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1243380020EvekeoANDAArbor Pharmaceuticals, Inc.2015-02-012017-09-30AMPHETAMINE SULFATEORALTABLETANDA200166bb12811f-4cce-4010-aa48-d17c46ca1d3a
2243380022EvekeoANDAArbor Pharmaceuticals, Inc.2015-11-01AMPHETAMINE SULFATEORALTABLETANDA200166f469fb38-0380-4621-9db3-a4f429126156

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA083901AMPHETAMINE SULFATETrueLANNETT CO INC1984-08-31ANDA083901_001, ANDA083901_002
2ANDA200166EVEKEOARBOR PHARMACEUTICALS LLC2012-08-09ANDA200166_001, ANDA200166_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA083901_001discontinuedAMPHETAMINE SULFATE (5MG)ORALTABLETFalse1984-08-31AMPHETAMINE SULFATE
2ANDA083901_002discontinuedAMPHETAMINE SULFATE (10MG)ORALTABLETFalse1984-08-31AMPHETAMINE SULFATE
3ANDA200166_001RXAMPHETAMINE SULFATE (5MG)ORALTABLETFalse2012-08-09EVEKEO
4ANDA200166_002RXAMPHETAMINE SULFATE (10MG)ORALTABLETTrue2012-08-09EVEKEO

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1bb12811f-4cce-4010-aa48-d17c46ca1d3a (view SPL)EVEKEO (amphetamine sulfate tablets, USP) CIIprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2015-11-113243380020, 243380021
2f469fb38-0380-4621-9db3-a4f429126156 (view SPL)EVEKEO (amphetamine sulfate tablets, USP) CIIprescriptionHuman PrescriptionArbor Pharmaceuticals, Inc.2015-11-101243380022, 243380026

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