Orange Book product · Brand (NDA)
VYVANSE
LISDEXAMFETAMINE DIMESYLATE
At a glance
Jan 28, 2017
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 28, 2017
9 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
LISDEXAMFETAMINE DIMESYLATE
Strength
10MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
AB
Application
NDA 208510
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025ARYNTABrand (NDA)
NDA 219847 · AZURITY
- 2014VYVANSEBrand (NDA)
NDA 021977 · TAKEDA PHARMS USA
- 2025LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 218987 · GRANULES
- 2024LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 202836 · SANDOZ
- 2024LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 218850 · SPECGX LLC
- 2024LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 219258 · GRANULES
- 2024LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 218604 · ELITE LABS INC
- 2024LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 218306 · MSN
- 2024LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 202827 · HIKMA
- 2023LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 202802 · ACTAVIS ELIZABETH
- 2023LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 217194 · ALKEM LABS LTD
- 2023LISDEXAMFETAMINE DIMESYLATEGeneric (ANDA)
ANDA 202830 · AMNEAL
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.
