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ACTIVE SUBSTANCE / INN

DEXTROAMPHETAMINE SULFATE

Brand name(s): DEXTROAMPHETAMINE SULFATE, DEXEDRINE SPANSULE, DELCOBESE, DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, DEXEDRINE, DEXTROSTAT, DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
FDA LISTED
PRESCRIPTION
DISCONTINUED
NONE (TENTATIVE APPROVAL)
ANDA211715
ANDA076536
ACTIVE SUBSTANCE
Dextroamphetamine Sulfate
REGULATORS
FDA
SPONSORS / MAH
EPIC PHARMA LLC, TEVA, BARR LABS INC
TOTAL APPLICATIONS
10
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DELCOBESEANDA083564TEVADiscontinued
DEXTROSTATANDA084051SHIREDiscontinued
DEXTROAMPHETAMINE SULFATEANDA090652EPIC PHARMA LLCDiscontinued
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEANDA205401ANI PHARMSPrescription
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEANDA211715SUN PHARM INDUSTRIESDiscontinued
DEXTROAMPHETAMINE SULFATEANDA040361BARRPrescription
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATEANDA206304COREPHARMANone (Tentative Approval)
DEXEDRINEANDA084935GLAXOSMITHKLINEDiscontinued
DEXEDRINE SPANSULENDA017078IMPAX LABS INCPrescription
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATEANDA076536BARR LABS INCDiscontinued

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