Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 005378
Company: RECORDATI RARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DESOXYN METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AA Yes Yes
DESOXYN METHAMPHETAMINE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
DESOXYN METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
DESOXYN METHAMPHETAMINE HYDROCHLORIDE 15MG TABLET, 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
12/31/1943 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/19/2017 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005378Orig1s034ltr.pdf
01/04/2017 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/005378Orig1s031ltr.pdf
04/17/2015 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/005378Orig1s030ltr.pdf
01/26/2015 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

12/03/2013 SUPPL-28 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s028ltr.pdf
08/23/2013 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/005378Orig1s027ltr.pdf
05/11/2007 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/005378s026ltr.pdf
04/12/2006 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/05378s024ltr.pdf
11/20/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/16/1999 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1998 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/06/2001 SUPPL-20 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf
07/27/1989 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/25/1983 SUPPL-16 Labeling

Label is not available on this site.

06/27/1983 SUPPL-15 Labeling

Label is not available on this site.

09/22/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/22/1984 SUPPL-13 Labeling

Label is not available on this site.

09/30/1981 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/30/1979 SUPPL-9 Labeling

Label is not available on this site.

07/22/1975 SUPPL-6 Labeling

Label is not available on this site.

07/22/1975 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

07/22/1975 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
05/19/2017 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s034lbl.pdf
01/04/2017 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/005378s031lbl.pdf
04/17/2015 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/005378s030lbl.pdf
12/03/2013 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/005378s028lbl.pdf
08/23/2013 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/0005378s027lbl.pdf
05/11/2007 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/005378s026lbl.pdf
04/12/2006 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/005378s024lbl.pdf
12/06/2001 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/05378s20ltr.pdf

DESOXYN

TABLET;ORAL; 5MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESOXYN METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AA 005378 RECORDATI RARE
METHAMPHETAMINE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 091189 MAYNE PHARMA INC
METHAMPHETAMINE HYDROCHLORIDE METHAMPHETAMINE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AA 203846 WEST-WARD PHARMS INT

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