Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 076137
Company: MAYNE PHARMA
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
01/18/2002 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
12/28/2015 SUPPL-17 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

03/02/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

01/28/2014 SUPPL-13 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/13/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

08/31/2007 SUPPL-7 Labeling

Label is not available on this site.

03/23/2007 SUPPL-6 Labeling

Label is not available on this site.

11/05/2002 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/2002 SUPPL-1 Manufacturing (CMC)-Manufacturing Process

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 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 205077 ANDA REPOSITORY
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076137 MAYNE PHARMA
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 209111 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076353 SPECGX LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205673 VINTAGE PHARMS

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 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 205077 ANDA REPOSITORY
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076137 MAYNE PHARMA
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 209111 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076353 SPECGX LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205673 VINTAGE PHARMS

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 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 205077 ANDA REPOSITORY
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076137 MAYNE PHARMA
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 209111 NESHER PHARMS
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 076353 SPECGX LLC
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 205673 VINTAGE PHARMS

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