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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203901
Company: ACTAVIS ELIZABETH

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB No No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/30/2012 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2024 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
10/25/2024 SUPPL-17 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/25/2024 SUPPL-16 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.
10/25/2024 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/25/2024 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
08/26/2015 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
04/03/2015 SUPPL-4 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 017078 IMPAX LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203901 ACTAVIS ELIZABETH
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076353 SPECGX LLC

CAPSULE, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 017078 IMPAX LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203901 ACTAVIS ELIZABETH
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076353 SPECGX LLC

CAPSULE, EXTENDED RELEASE;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXEDRINE SPANSULE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription Yes AB 017078 IMPAX LABS INC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203901 ACTAVIS ELIZABETH
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076353 SPECGX LLC
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