Orange Book product · Generic (ANDA)
TOPIRAMATE
TOPIRAMATE
At a glance
May 04, 2023
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 04, 2023
3 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPIRAMATE
Strength
25MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB1
Application
ANDA 205976
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TOPIRAMATE
- 2021EPRONTIABrand (NDA)
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- 2014QUDEXY XRBrand (NDA)
NDA 205122 · UPSHER SMITH LABS
- 2013TROKENDI XRBrand (NDA)
NDA 201635 · SUPERNUS PHARMS
- 1998TOPAMAXBrand (NDA)
NDA 020844 · JANSSEN PHARMS
- 1996TOPAMAXBrand (NDA)
NDA 020505 · JANSSEN PHARMS
- 2026TOPIRAMATEGeneric (ANDA)
ANDA 220041 · RICONPHARMA LLC
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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
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.
