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Approved Drug Products containing Clobazam listed in the FDA Orange Book. Original Data : FDA Website

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01 3TARO

02 3BRECKENRIDGE

03 3ACCORD HLTHCARE

04 4ALKEM LABS LTD

05 1AMNEAL

06 2AMNEAL PHARMS CO

07 2APOTEX

08 1AUROBINDO PHARMA LTD

09 3BIONPHARMA

10 2CELLTRION

11 3CHARTWELL MOLECULAR

12 3HETERO LABS LTD III

13 3HIKMA

14 4LUNDBECK PHARMS LLC

15 3LUPIN LTD

16 2MICRO LABS

17 2MSN

18 1NORVIUM BIOSCIENCE

19 3OTTER PHARMS

20 2PIRAMAL

21 1TEVA PHARMS USA

22 3UPSHER SMITH LABS

23 1VISTAPHARM

24 2ZYDUS PHARMS

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PharmaCompass

01

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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : CLOBAZAM

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2018-10-22

Application Number : 209308

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

02

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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : CLOBAZAM

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2018-10-22

Application Number : 209440

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : CLOBAZAM

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2018-10-22

Application Number : 209440

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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04

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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : CLOBAZAM

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 2.5MG/ML

Approval Date : 2019-04-15

Application Number : 210978

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : CLOBAZAM

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2018-10-22

Application Number : 209308

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

06

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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : CLOBAZAM

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2021-10-19

Application Number : 209308

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Breckenridge Pharmaceutical

07

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : ONFI

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 2011-10-21

Application Number : 202067

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : ONFI

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2011-10-21

Application Number : 202067

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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09

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : ONFI

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2011-10-21

Application Number : 202067

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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10

Luxepack
Not Confirmed
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Luxepack
Not Confirmed

CLOBAZAM

Brand Name : ONFI

Dosage Form : SUSPENSION;ORAL

Dosage Strength : 2.5MG/ML

Approval Date : 2012-12-14

Application Number : 203993

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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