Orange Book product · Generic (ANDA)
DALFAMPRIDINE
DALFAMPRIDINE
At a glance
Oct 24, 2018
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 24, 2018
7 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
DALFAMPRIDINE
Strength
10MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
ANDA 206646
Product number
001
Marketing status
DISCN
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 206765 · ALKEM LABS LTD
- 2018DALFAMPRIDINEGeneric (ANDA)
ANDA 206863 · ACCORD HLTHCARE
- 2017DALFAMPRIDINEGeneric (ANDA)
ANDA 206836 · ACTAVIS LABS FL INC
- 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.
