FDA Orange Book · active-ingredient family
Atovaquone; proguanil hydrochloride
Atovaquone; proguanil hydrochloride is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MALARONE · NDA 021078
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MALARONERLD×2 | GLAXOSMITHKLINE | NDA 021078 | AB | Jul 14, 2000 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE×2 | GLENMARK PHARMS LTD | ANDA 091211 | AB | Apr 06, 2015 | |
| ATOVAQUONE AND PROGUANIL HYDROCHLORIDE×2 | MYLAN | ANDA 202362 | AB | May 27, 2014 |
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.
Atovaquone; proguanil hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
