Orange Book product · Brand (NDA)
TOPAMAX
TOPIRAMATE
At a glance
Dec 24, 1996
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 24, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPIRAMATE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020505
Product number
004
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.
- 2021EPRONTIABrand (NDA)
NDA 214679 · AZURITY
- 2014QUDEXY XRBrand (NDA)
NDA 205122 · UPSHER SMITH LABS
- 2013TROKENDI XRBrand (NDA)
NDA 201635 · SUPERNUS PHARMS
- 1998TOPAMAXBrand (NDA)
NDA 020844 · JANSSEN PHARMS
- 2026TOPIRAMATEGeneric (ANDA)
ANDA 220041 · RICONPHARMA LLC
- 2026TOPIRAMATEGeneric (ANDA)
ANDA 217443 · ASCENT PHARMS INC
- 2025TOPIRAMATEGeneric (ANDA)
ANDA 219564 · AJANTA PHARMA LTD
- 2025TOPIRAMATEGeneric (ANDA)
ANDA 216683 · RUBICON RESEARCH
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218695 · AMTA
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 215638 · XIAMEN LP PHARM CO
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 217795 · ALKEM LABS LTD
- 2024TOPIRAMATEGeneric (ANDA)
ANDA 218642 · SENORES PHARMS
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.
