FDA Orange Book · active-ingredient family
Hydroxychloroquine sulfate
Hydroxychloroquine sulfate is approved as 2 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOVUNA · NDA 214581
2
Brand (NDA)
15
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOVUNARLD×2 | NOVITIUM PHARMA | NDA 214581 | — | Jan 14, 2022 | |
| PLAQUENILRLD | ADVANZ PHARMA | NDA 009768 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (15)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROXYCHLOROQUINE SULFATE×4 | APPCO | ANDA 210441 | AB | Sep 19, 2022 | |
| HYDROXYCHLOROQUINE SULFATE×4 | ACCORD HLTHCARE | ANDA 213342 | AB | Aug 18, 2021 | |
| HYDROXYCHLOROQUINE SULFATE | SENORES PHARMS | ANDA 212902 | AB | May 14, 2020 | |
| HYDROXYCHLOROQUINE SULFATE | LAURUS | ANDA 210959 | AB | Jan 15, 2019 | |
| HYDROXYCHLOROQUINE SULFATE | CHARTWELL RX | ANDA 210543 | AB | Jul 06, 2018 | |
| HYDROXYCHLOROQUINE SULFATE | AMNEAL PHARMS CO | ANDA 210577 | AB | May 15, 2018 | |
| HYDROXYCHLOROQUINE SULFATE | ALKALOIDA ZRT | ANDA 201691 | AB | May 08, 2018 | |
| HYDROXYCHLOROQUINE SULFATE | ZYDUS PHARMS USA INC | ANDA 040657 | AB | Sep 21, 2007 | |
| HYDROXYCHLOROQUINE SULFATE | HIKMA PHARMS | ANDA 040760 | — | Aug 15, 2007 | |
| HYDROXYCHLOROQUINE SULFATE | IPCA LABS LTD | ANDA 040766 | AB | Jun 14, 2007 | |
| HYDROXYCHLOROQUINE SULFATE | AUROBINDO PHARMA USA | ANDA 040274 | AB | May 29, 1998 | |
| HYDROXYCHLOROQUINE SULFATE | CREEKWOOD PHARMS | ANDA 040150 | AB | Jan 27, 1996 | |
| HYDROXYCHLOROQUINE SULFATE | SANDOZ | ANDA 040104 | AB | Nov 30, 1995 | |
| HYDROXYCHLOROQUINE SULFATE | WATSON LABS | ANDA 040133 | — | Nov 30, 1995 | |
| HYDROXYCHLOROQUINE SULFATE | TEVA PHARMS | ANDA 040081 | AB | Sep 30, 1994 |
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.
Hydroxychloroquine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
