Orange Book product · Brand (NDA)
ZYPREXA
OLANZAPINE
At a glance
Mar 29, 2004
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 29, 2004
22 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
OLANZAPINE
Strength
10MG/VIAL
Dosage form
POWDER
Route
INTRAMUSCULAR
TE code
AP
Application
NDA 021253
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2000ZYPREXA ZYDISBrand (NDA)
NDA 021086 · CHEPLAPHARM
- 1996ZYPREXABrand (NDA)
NDA 020592 · CHEPLAPHARM
- 2026OLANZAPINEGeneric (ANDA)
ANDA 220323 · ANTHEA PHARMA
- 2026OLANZAPINEGeneric (ANDA)
ANDA 219048 · OMNIVIUM PHARMS
- 2025OLANZAPINEGeneric (ANDA)
ANDA 211072 · UBI
- 2025OLANZAPINEGeneric (ANDA)
ANDA 218116 · QILU
- 2023OLANZAPINEGeneric (ANDA)
ANDA 217466 · ASPIRO
- 2023OLANZAPINEGeneric (ANDA)
ANDA 202889 · ZYDUS PHARMS
- 2023OLANZAPINEGeneric (ANDA)
ANDA 210022 · CADILA PHARMS LTD
- 2020OLANZAPINEGeneric (ANDA)
ANDA 206892 · HISUN PHARM HANGZHOU
- 2020OLANZAPINEGeneric (ANDA)
ANDA 206924 · HISUN PHARM HANGZHOU
- 2020OLANZAPINEGeneric (ANDA)
ANDA 210968 · EUGIA PHARMA
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.
