Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210833

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SYMPAZAN (CLOBAZAM)
5MG
Marketing Status: Prescription

Active Ingredient: CLOBAZAM
Proprietary Name: SYMPAZAN
Dosage Form; Route of Administration: FILM; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210833
Product Number: 001
Approval Date: Nov 1, 2018
Applicant Holder Full Name: OTTER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMPAZAN (CLOBAZAM)
10MG
Marketing Status: Prescription

Active Ingredient: CLOBAZAM
Proprietary Name: SYMPAZAN
Dosage Form; Route of Administration: FILM; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210833
Product Number: 002
Approval Date: Nov 1, 2018
Applicant Holder Full Name: OTTER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

SYMPAZAN (CLOBAZAM)
20MG
Marketing Status: Prescription

Active Ingredient: CLOBAZAM
Proprietary Name: SYMPAZAN
Dosage Form; Route of Administration: FILM; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210833
Product Number: 003
Approval Date: Nov 1, 2018
Applicant Holder Full Name: OTTER PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information