Orange Book product · Generic (ANDA)
AMPHETAMINE
AMPHETAMINE
Generic (ANDA)ANDA 209253TE ABRX ACTAVIS LABS FL INC
At a glance
Jun 22, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 22, 2023
3 yr ago
Today
Pharmaceutical detail
Active ingredient
AMPHETAMINE
Strength
EQ 3.1MG BASE
Dosage form
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 209253
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMPHETAMINE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
