Orange Book product · Brand (NDA)
ONFI
CLOBAZAM
At a glance
Dec 14, 2012
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 2012
13 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOBAZAM
Strength
2.5MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 203993
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.
- 2018SYMPAZANBrand (NDA)
NDA 210833 · ASSERTIO SPECLTY
- 2011ONFIBrand (NDA)
NDA 202067 · LUNDBECK PHARMS LLC
- 2022CLOBAZAMGeneric (ANDA)
ANDA 216008 · ACCORD HLTHCARE
- 2022CLOBAZAMGeneric (ANDA)
ANDA 214404 · AUROBINDO PHARMA LTD
- 2021CLOBAZAMGeneric (ANDA)
ANDA 209308 · NOVITIUM PHARMA
- 2021CLOBAZAMGeneric (ANDA)
ANDA 213404 · MSN
- 2021CLOBAZAMGeneric (ANDA)
ANDA 213039 · ALKEM LABS LTD
- 2020CLOBAZAMGeneric (ANDA)
ANDA 212714 · ALKEM LABS LTD
- 2020CLOBAZAMGeneric (ANDA)
ANDA 211959 · CHARTWELL RX
- 2020CLOBAZAMGeneric (ANDA)
ANDA 209853 · APOTEX
- 2020CLOBAZAMGeneric (ANDA)
ANDA 213110 · CHARTWELL MOLECULAR
- 2020CLOBAZAMGeneric (ANDA)
ANDA 209796 · HETERO LABS LTD III
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.
