Orange Book product · Generic (ANDA)
CLOBAZAM
CLOBAZAM
At a glance
May 11, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 11, 2021
5 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOBAZAM
Strength
10MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 213404
Product number
001
Marketing status
RX
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 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.
