Orange Book product · Generic (ANDA)
HYDROXYCHLOROQUINE SULFATE
HYDROXYCHLOROQUINE SULFATE
At a glance
Sep 19, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 19, 2022
3 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYCHLOROQUINE SULFATE
Strength
100MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 210441
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of HYDROXYCHLOROQUINE SULFATE
- 2022SOVUNABrand (NDA)
NDA 214581 · NOVITIUM PHARMA
- —PLAQUENILBrand (NDA)
NDA 009768 · ADVANZ PHARMA
- 2021HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 213342 · ACCORD HLTHCARE
- 2020HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 212902 · SENORES PHARMS
- 2019HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 210959 · LAURUS
- 2018HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 210543 · CHARTWELL RX
- 2018HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 210577 · AMNEAL PHARMS CO
- 2018HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 201691 · ALKALOIDA ZRT
- 2007HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 040657 · ZYDUS PHARMS USA INC
- 2007HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 040760 · HIKMA PHARMS
- 2007HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 040766 · IPCA LABS LTD
- 1998HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 040274 · AUROBINDO PHARMA USA
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.
