Orange Book product · Brand (NDA)
MEZOFY
ARIPIPRAZOLE
At a glance
Apr 15, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 2025
1 yr 2 mo ago
Today
Patent 9694008 expires
Listed drug product patent expiration.
Aug 07, 2033
in 7 yr 3 mo
Pharmaceutical detail
Active ingredient
ARIPIPRAZOLE
Strength
5MG
Dosage form
FILM
Route
ORAL
TE code
Not listed
Application
NDA 211448
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.
- 2024OPIPZABrand (NDA)
NDA 216655 · XIAMEN LP PHARM CO
- 2023ABILIFY ASIMTUFIIBrand (NDA)
NDA 217006 · OTSUKA
- 2017ABILIFY MYCITE KITBrand (NDA)
NDA 207202 · OTSUKA
- 2013ABILIFY MAINTENA KITBrand (NDA)
NDA 202971 · OTSUKA PHARM CO LTD
- 2006ABILIFYBrand (NDA)
NDA 021866 · OTSUKA
- 2006ABILIFYBrand (NDA)
NDA 021729 · OTSUKA
- 2004ABILIFYBrand (NDA)
NDA 021713 · OTSUKA
- 2002ABILIFYBrand (NDA)
NDA 021436 · OTSUKA
- 2026ARIPIPRAZOLEGeneric (ANDA)
ANDA 216208 · AUROBINDO PHARMA
- 2025ARIPIPRAZOLEGeneric (ANDA)
ANDA 215582 · QUAGEN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 216608 · MYLAN
- 2024ARIPIPRAZOLEGeneric (ANDA)
ANDA 205589 · LUPIN
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9694008 | Aug 07, 2033 | in 7 yr 3 mo | Product |
