Orange Book product · Brand (NDA)
SEROQUEL XR
QUETIAPINE FUMARATE
At a glance
May 17, 2007
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 17, 2007
19 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
QUETIAPINE FUMARATE
Strength
EQ 50MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 022047
Product number
001
Marketing status
RX
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.
- 1997SEROQUELBrand (NDA)
NDA 020639 · CHEPLAPHARM
- 2024QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 211144 · RISING
- 2024QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 205983 · IPCA LABS LTD
- 2022QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 206954 · PRINSTON INC
- 2022QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 215478 · UNICHEM
- 2022QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 204316 · HETERO LABS LTD V
- 2022QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 208781 · PRINSTON INC
- 2021QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 202228 · RISING
- 2018QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 209635 · SCIEGEN PHARMS
- 2018QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 211405 · AMNEAL PHARMS
- 2018QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 209497 · ALIGNSCIENCE PHARMA
- 2017QUETIAPINE FUMARATEGeneric (ANDA)
ANDA 090757 · PH HEALTH
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.
