Product Details for NDA 202067
ONFI (CLOBAZAM)
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG
Marketing Status: Prescription
Active Ingredient: CLOBAZAM
Proprietary Name: ONFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202067
Product Number: 002
Approval Date: Oct 21, 2011
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ONFI (CLOBAZAM)
Proprietary Name: ONFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202067
Product Number: 002
Approval Date: Oct 21, 2011
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: CLOBAZAM
Proprietary Name: ONFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202067
Product Number: 003
Approval Date: Oct 21, 2011
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ONFI (CLOBAZAM)
Proprietary Name: ONFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202067
Product Number: 003
Approval Date: Oct 21, 2011
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: CLOBAZAM
Proprietary Name: ONFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202067
Product Number: 001
Approval Date: Oct 21, 2011
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ONFI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N202067
Product Number: 001
Approval Date: Oct 21, 2011
Applicant Holder Full Name: LUNDBECK PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information