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ACTIVE SUBSTANCE / INN

DEXTROAMPHETAMINE SACCHARATE

Brand name(s): ADDERALL 5, DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, ADDERALL 7.5, DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, ADDERALL 10, ADDERALL 15, ADDERALL 12.5, ADDERALL 20, DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA211715
ANDA076536
ACTIVE SUBSTANCE
Dextroamphetamine Saccharate
REGULATORS
FDA
SPONSORS / MAH
BARR LABS INC, ANI PHARMS, COREPHARMA
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEANDA205401ANI PHARMSPrescription
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEANDA211715SUN PHARM INDUSTRIESDiscontinued
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATEANDA206304COREPHARMANone (Tentative Approval)
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATEANDA076536BARR LABS INCDiscontinued
ADDERALL 5NDA011522TEVA WOMENSDiscontinued
ADDERALL 10NDA011522TEVA WOMENSDiscontinued
ADDERALL 15NDA011522TEVA WOMENSDiscontinued
ADDERALL 7.5NDA011522TEVA WOMENSDiscontinued
ADDERALL 20NDA011522TEVA WOMENSDiscontinued
ADDERALL 12.5NDA011522TEVA WOMENSDiscontinued

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