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Last Updated: December 31, 2025

Details for New Drug Application (NDA): 083563

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NDA 083563 describes DELCOBESE, which is a drug marketed by Teva and is included in two NDAs. Additional details are available on the DELCOBESE profile page.

The generic ingredient in DELCOBESE is amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Additional details are available on the amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate profile page.

Summary for 083563

Tradename:	DELCOBESE
Applicant:	Teva
Ingredient:	amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG;5MG;5MG;5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	3.75MG;3.75MG;3.75MG;3.75MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG;2.5MG;2.5MG;2.5MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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