Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017078
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXEDRINE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
DEXEDRINE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes No
DEXEDRINE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/02/1976 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/15/2019 SUPPL-52 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/017078Orig1s052ltr.pdf
05/19/2017 SUPPL-50 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017078Orig1s050ltr.pdf
01/04/2017 SUPPL-49 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017078Orig1s049ltr.pdf
04/17/2015 SUPPL-48 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017078Orig1s048ltr.pdf
12/06/2013 SUPPL-47 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s047ltr.pdf
06/11/2013 SUPPL-46 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017078Orig1s046ltr.pdf
05/23/2008 SUPPL-44 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017078s044ltr.pdf
05/01/2007 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017078s042ltr.pdf
08/10/2006 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017078s040LTR.pdf
10/20/2000 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/2000 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/07/1999 SUPPL-36 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/07/1999 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

11/03/1999 SUPPL-34 Labeling

Label is not available on this site.

12/03/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

04/06/1998 SUPPL-30 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/09/1997 SUPPL-27 Labeling

Label is not available on this site.

09/12/1994 SUPPL-25 Labeling

Label is not available on this site.

07/21/1993 SUPPL-22 Labeling

Label is not available on this site.

12/16/1987 SUPPL-21 Labeling

Label is not available on this site.

12/02/1987 SUPPL-20 Labeling

Label is not available on this site.

08/25/1982 SUPPL-19 Labeling

Label is not available on this site.

08/25/1982 SUPPL-18 Labeling

Label is not available on this site.

02/22/1983 SUPPL-17 Labeling

Label is not available on this site.

10/06/1980 SUPPL-16 Labeling

Label is not available on this site.

09/19/1980 SUPPL-15 Labeling

Label is not available on this site.

08/29/1980 SUPPL-14 Labeling

Label is not available on this site.

08/29/1980 SUPPL-13 Labeling

Label is not available on this site.

08/29/1980 SUPPL-12 Labeling

Label is not available on this site.

04/16/1980 SUPPL-11 Labeling

Label is not available on this site.

08/30/1979 SUPPL-9 Labeling

Label is not available on this site.

06/27/1979 SUPPL-8 Labeling

Label is not available on this site.

06/06/1979 SUPPL-7 Labeling

Label is not available on this site.

03/30/1979 SUPPL-5 Labeling

Label is not available on this site.

03/30/1979 SUPPL-3 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/15/2019 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/017078s052lbl.pdf
05/19/2017 SUPPL-50 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s050lbl.pdf
01/04/2017 SUPPL-49 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017078s049lbl.pdf
04/17/2015 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017078s048lbl.pdf
12/06/2013 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s047lbl.pdf
06/11/2013 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017078s046lbl.pdf
05/23/2008 SUPPL-44 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017078s044lbl.pdf
05/01/2007 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017078s042lbl.pdf
08/10/2006 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017078s040lbl.pdf

DEXEDRINE

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 076137 MAYNE PHARMA
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 5MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206735 MYLAN
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 205077 PII
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 076137 MAYNE PHARMA
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206735 MYLAN
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 205077 PII
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 076137 MAYNE PHARMA
DEXTROAMPHETAMINE SULFATE DEXTROAMPHETAMINE SULFATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 206735 MYLAN
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 205077 PII
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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