Orange Book product · Generic (ANDA)
CLOBAZAM
CLOBAZAM
At a glance
Jul 10, 2019
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 10, 2019
7 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOBAZAM
Strength
2.5MG/ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 210746
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CLOBAZAM
- 2018SYMPAZANBrand (NDA)
NDA 210833 · ASSERTIO SPECLTY
- 2012ONFIBrand (NDA)
NDA 203993 · LUNDBECK PHARMS LLC
- 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
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.
