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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 011522

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NDA 011522 describes ADDERALL 7.5, which is a drug marketed by Teva Womens and is included in one NDA. Additional details are available on the ADDERALL 7.5 profile page.

The generic ingredient in ADDERALL 7.5 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

Summary for 011522

Tradename:	ADDERALL 7.5
Applicant:	Teva Womens
Ingredient:	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
Patents:	0

Profile for product number 007

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG;2.5MG;2.5MG;2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 13, 1996	TE:		RLD:	Yes

Profile for product number 008

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG;5MG;5MG;5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 13, 1996	TE:		RLD:	Yes

Profile for product number 009

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	1.25MG;1.25MG;1.25MG;1.25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 12, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 011522

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Womens	ADDERALL 10	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-007	Feb 13, 1996	⤷ Start Trial	⤷ Start Trial
Teva Womens	ADDERALL 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-009	May 12, 1997	⤷ Start Trial	⤷ Start Trial
Teva Womens	ADDERALL 12.5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-012	Aug 31, 2000	⤷ Start Trial	⤷ Start Trial
Teva Womens	ADDERALL 30	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	011522-010	May 12, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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