Orange Book product · Generic (ANDA)
CLOBAZAM
CLOBAZAM
At a glance
Dec 21, 2020
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2020
5 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
CLOBAZAM
Strength
5MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 212714
Product number
003
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 213404 · MSN
- 2021CLOBAZAMGeneric (ANDA)
ANDA 213039 · 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.
