FDA Orange Book · active-ingredient family
Quinine sulfate
Quinine sulfate is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:QUALAQUIN · NDA 021799
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUALAQUINRLD | SUN PHARM INDUSTRIES | NDA 021799 | — | Aug 12, 2005 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUININE SULFATE | INGENUS PHARMS LLC | ANDA 204372 | AB | Jul 22, 2015 | |
| QUININE SULFATE | AMNEAL PHARMS | ANDA 203729 | AB | Jul 15, 2015 | |
| QUININE SULFATE | LUPIN | ANDA 203112 | AB | Apr 24, 2015 | |
| QUININE SULFATE | AUROBINDO PHARMA USA | ANDA 202581 | — | Dec 14, 2012 | |
| QUININE SULFATE | TEVA PHARMS | ANDA 091661 | AB | Sep 28, 2012 |
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.
Quinine sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
