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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 005378
Company: KEY THERAP
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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/25/2022 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/005378s037lbl.pdf
04/11/2019 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/005378s035lbl.pdf
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
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