Orange Book product · Generic (ANDA)
FINGOLIMOD HYDROCHLORIDE
FINGOLIMOD HYDROCHLORIDE
At a glance
Dec 04, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 04, 2019
6 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
FINGOLIMOD HYDROCHLORIDE
Strength
EQ 0.5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 207979
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FINGOLIMOD HYDROCHLORIDE
- 2018GILENYABrand (NDA)
NDA 022527 · NOVARTIS
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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 212152 · TEVA PHARMS USA
- 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
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.
