FDA.report

Application 090533

Type
ANDA
Sponsor
ARBOR PHARMS LLC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL2.5MGNoNo
002DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
003DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL7.5MGNoNo
004DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL10MGNoNo
005DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL15MGNoNo
006DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL20MGNoNo
007DEXTROAMPHETAMINE SULFATEDEXTROAMPHETAMINE SULFATETABLET;ORAL30MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-850ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-851ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-852ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-853ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-854ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-855ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
24338-856ZenzediDextroamphetamine SulfateArbor Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-500Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-510Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-515Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-515Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-520Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-520Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-530Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent
52536-530Dextroamphetamine SulfateDextroamphetamine SulfateWilshire Pharmaceuticals, Inc.ANDACurrent

Documents

DocumentSubmission typeDate
85123SUPPL 2026-02-24
85122SUPPL 2026-02-24