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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

ANDA

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE | A210876 | TEVA PHARMACEUTICALS USA INC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: MYDAYIS(TE code: AB2)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shire Development LLC et al v. Teva Pharmaceuticals USA, Inc. et al 1:2017cv01696 3 patentsANDA 210876Mixed salts of a single-entity amphetamine	D. Del.	2017-11-22	Terminated 2019-11-08	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 4, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 3.125MG;3.125MG;3.125MG;3.125MG

AB2

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 31, 2022

No patent or exclusivity listings for this strength.

#002 — 6.25MG;6.25MG;6.25MG;6.25MG

AB2

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 31, 2022

#003 — 9.375MG;9.375MG;9.375MG;9.375MG

AB2

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 31, 2022

#004 — 12.5MG;12.5MG;12.5MG;12.5MG

AB2

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 31, 2022