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Generated: January 22, 2018

DrugPatentWatch Database Preview

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. Four 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
Therapeutic Class:Central Nervous System Agents
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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Colorcon
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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