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Generated: December 18, 2018

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Details for New Drug Application (NDA): 005378

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NDA 005378 describes DESOXYN, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. Additional details are available on the DESOXYN profile page.

The generic ingredient in DESOXYN is methamphetamine hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the methamphetamine hydrochloride profile page.
Summary for 005378
Tradename:DESOXYN
Applicant:Recordati Rare
Ingredient:methamphetamine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 005378
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DESOXYN methamphetamine hydrochloride TABLET, EXTENDED RELEASE;ORAL 005378 NDA RECORDATI RARE DISEASES, INC. 55292-104 55292-104-01 100 TABLET in 1 BOTTLE (55292-104-01)
DESOXYN methamphetamine hydrochloride TABLET;ORAL 005378 NDA RECORDATI RARE DISEASES, INC. 55292-104 55292-104-01 100 TABLET in 1 BOTTLE (55292-104-01)

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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