Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 217186

CREXONT (CARBIDOPA; LEVODOPA)
35MG;140MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CREXONT
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 35MG;140MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N217186
Product Number: 001
Approval Date: Aug 7, 2024
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information

CREXONT (CARBIDOPA; LEVODOPA)
52.5MG;210MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CREXONT
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 52.5MG;210MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N217186
Product Number: 002
Approval Date: Aug 7, 2024
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information

CREXONT (CARBIDOPA; LEVODOPA)
70MG;280MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CREXONT
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 70MG;280MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N217186
Product Number: 003
Approval Date: Aug 7, 2024
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information

CREXONT (CARBIDOPA; LEVODOPA)
87.5MG;350MG
Marketing Status: Prescription

Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: CREXONT
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 87.5MG;350MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N217186
Product Number: 004
Approval Date: Aug 7, 2024
Applicant Holder Full Name: IMPAX LABORATORIES LLC
Marketing Status: Prescription
Patent and Exclusivity Information