Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076536
Company: BARR LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 1.25MG;1.25MG;1.25MG;1.25MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 2.5MG;2.5MG;2.5MG;2.5MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 3.75MG;3.75MG;3.75MG;3.75MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 5MG;5MG;5MG;5MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 6.25MG;6.25MG;6.25MG;6.25MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE 7.5MG;7.5MG;7.5MG;7.5MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None 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
02/12/2013 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
09/02/2015 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/21/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

01/21/2014 SUPPL-1 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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