Orange Book product · Brand (NDA)
QUALAQUIN
QUININE SULFATE
At a glance
Aug 12, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 12, 2005
21 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
QUININE SULFATE
Strength
324MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021799
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.
- 2015QUININE SULFATEGeneric (ANDA)
ANDA 204372 · INGENUS PHARMS LLC
- 2015QUININE SULFATEGeneric (ANDA)
ANDA 203729 · AMNEAL PHARMS
- 2015QUININE SULFATEGeneric (ANDA)
ANDA 203112 · LUPIN
- 2012QUININE SULFATEGeneric (ANDA)
ANDA 202581 · AUROBINDO PHARMA USA
- 2012QUININE SULFATEGeneric (ANDA)
ANDA 091661 · TEVA 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.
