Orange Book product · Generic (ANDA)
ATOVAQUONE
ATOVAQUONE
At a glance
May 31, 2019
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 31, 2019
7 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
ATOVAQUONE
Strength
750MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 210510
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ATOVAQUONE
- 1995MEPRONBrand (NDA)
NDA 020500 · GLAXOSMITHKLINE LLC
- 1992MEPRONBrand (NDA)
NDA 020259 · GLAXOSMITHKLINE LLC
- 2021ATOVAQUONEGeneric (ANDA)
ANDA 214272 · PAI HOLDINGS
- 2021ATOVAQUONEGeneric (ANDA)
ANDA 212918 · BIONPHARMA
- 2018ATOVAQUONEGeneric (ANDA)
ANDA 209685 · GLENMARK SPECLT
- 2018ATOVAQUONEGeneric (ANDA)
ANDA 210692 · HETERO LABS LTD III
- 2018ATOVAQUONEGeneric (ANDA)
ANDA 209105 · LUPIN
- 2017ATOVAQUONEGeneric (ANDA)
ANDA 209750 · APOTEX
- 2017ATOVAQUONEGeneric (ANDA)
ANDA 207833 · CHARTWELL RX
- 2014ATOVAQUONEGeneric (ANDA)
ANDA 202960 · AMNEAL PHARMS
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.
