Orange Book product · Brand (NDA)
MEPRON
ATOVAQUONE
At a glance
Nov 25, 1992
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 25, 1992
34 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
ATOVAQUONE
Strength
250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020259
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 1995MEPRONBrand (NDA)
NDA 020500 · 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.
