Orange Book product · Brand (NDA)
MEPRON
ATOVAQUONE
At a glance
Feb 08, 1995
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 08, 1995
31 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
ATOVAQUONE
Strength
750MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 020500
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.
- 1992MEPRONBrand (NDA)
NDA 020259 · GLAXOSMITHKLINE LLC
- 2021ATOVAQUONEGeneric (ANDA)
ANDA 214272 · PAI HOLDINGS
- 2021ATOVAQUONEGeneric (ANDA)
ANDA 212918 · BIONPHARMA
- 2019ATOVAQUONEGeneric (ANDA)
ANDA 210510 · ABHAI LLC
- 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.
