Orange Book product · Brand (NDA)
PLAQUENIL
HYDROXYCHLOROQUINE SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROXYCHLOROQUINE SULFATE
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 009768
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022SOVUNABrand (NDA)
NDA 214581 · NOVITIUM PHARMA
- 2022HYDROXYCHLOROQUINE SULFATEGeneric (ANDA)
ANDA 210441 · APPCO
- 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.
