Orange Book product · Generic (ANDA)
FINGOLIMOD HYDROCHLORIDE
FINGOLIMOD HYDROCHLORIDE
At a glance
Nov 12, 2021
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 12, 2021
4 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FINGOLIMOD HYDROCHLORIDE
Strength
EQ 0.25MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
ANDA 212152
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FINGOLIMOD HYDROCHLORIDE
- 2018GILENYABrand (NDA)
NDA 022527 · NOVARTIS
- 2026FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 207974 · ALEMBIC
- 2024FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 207983 · AUROBINDO PHARMA LTD
- 2023FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 207945 · EZRA VENTURES
- 2023FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 210252 · BIONPHARMA
- 2022FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 208003 · PRINSTON INC
- 2021FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 207939 · HEC PHARM CO LTD
- 2021FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 208000 · DR REDDYS
- 2021FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 208005 · MYLAN
- 2020FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 208004 · ALKEM LABS LTD
- 2020FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 207993 · APOTEX
- 2020FINGOLIMOD HYDROCHLORIDEGeneric (ANDA)
ANDA 207991 · ACCORD HLTHCARE
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.
