Orange Book product · Brand (NDA)
ALBENZA
ALBENDAZOLE
At a glance
Jun 11, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 11, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
ALBENDAZOLE
Strength
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 020666
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.
- 2024ALBENDAZOLEGeneric (ANDA)
ANDA 215652 · ALEMBIC
- 2021ALBENDAZOLEGeneric (ANDA)
ANDA 211034 · DR REDDYS
- 2021ALBENDAZOLEGeneric (ANDA)
ANDA 213435 · MSN
- 2020ALBENDAZOLEGeneric (ANDA)
ANDA 211636 · CHARTWELL RX
- 2019ALBENDAZOLEGeneric (ANDA)
ANDA 208094 · ACTAVIS ELIZABETH
- 2019ALBENDAZOLEGeneric (ANDA)
ANDA 211117 · EDENBRIDGE PHARMS
- 2018ALBENDAZOLEGeneric (ANDA)
ANDA 208979 · ZYDUS PHARMS
- 2018ALBENDAZOLEGeneric (ANDA)
ANDA 210011 · STRIDES PHARMA
- 2018ALBENDAZOLEGeneric (ANDA)
ANDA 210434 · CIPLA LTD
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.
