Orange Book product · Brand (NDA)
LAMICTAL
LAMOTRIGINE
At a glance
Dec 27, 1994
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 27, 1994
31 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
LAMOTRIGINE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020241
Product number
005
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2025SUBVENITEBrand (NDA)
NDA 218879 · OWP PHARMS
- 2009LAMICTAL XRBrand (NDA)
NDA 022115 · GLAXOSMITHKLINE LLC
- 2009LAMICTAL ODTBrand (NDA)
NDA 022251 · GLAXOSMITHKLINE LLC
- 2000LAMICTAL CDBrand (NDA)
NDA 020764 · GLAXOSMITHKLINE LLC
- 2026LAMOTRIGINEGeneric (ANDA)
ANDA 217278 · ALEMBIC
- 2026LAMOTRIGINEGeneric (ANDA)
ANDA 217100 · TORRENT
- 2025LAMOTRIGINEGeneric (ANDA)
ANDA 219677 · TARO
- 2024LAMOTRIGINEGeneric (ANDA)
ANDA 211821 · ALEMBIC
- 2024LAMOTRIGINEGeneric (ANDA)
ANDA 204499 · IPCA LABS
- 2022LAMOTRIGINEGeneric (ANDA)
ANDA 214124 · AMRING PHARMS
- 2021LAMOTRIGINEGeneric (ANDA)
ANDA 213949 · YILING
- 2021LAMOTRIGINEGeneric (ANDA)
ANDA 213271 · AJANTA PHARMA LTD
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.
