Orange Book product · Generic (ANDA)
DALFAMPRIDINE
DALFAMPRIDINE
At a glance
Jan 23, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 23, 2017
9 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
DALFAMPRIDINE
Strength
10MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
ANDA 206836
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DALFAMPRIDINE
- 2010AMPYRABrand (NDA)
NDA 022250 · MERZ
- 2020DALFAMPRIDINEGeneric (ANDA)
ANDA 206858 · RISING
- 2019DALFAMPRIDINEGeneric (ANDA)
ANDA 208292 · SUN PHARM
- 2019DALFAMPRIDINEGeneric (ANDA)
ANDA 210158 · MICRO LABS
- 2018DALFAMPRIDINEGeneric (ANDA)
ANDA 206646 · HIKMA
- 2018DALFAMPRIDINEGeneric (ANDA)
ANDA 206765 · ALKEM LABS LTD
- 2018DALFAMPRIDINEGeneric (ANDA)
ANDA 206863 · ACCORD HLTHCARE
- 2017DALFAMPRIDINEGeneric (ANDA)
ANDA 206811 · AUROBINDO PHARMA
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.
