Orange Book product · Brand (NDA)
ZYPREXA ZYDIS
OLANZAPINE
At a glance
Apr 06, 2000
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 06, 2000
26 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
OLANZAPINE
Strength
5MG
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
AB
Application
NDA 021086
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.
- 2004ZYPREXABrand (NDA)
NDA 021253 · 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.
