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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203312

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RYTARY (CARBIDOPA; LEVODOPA)
23.75MG;95MG
Marketing Status: Prescription
Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: RYTARY
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 23.75MG;95MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203312
Product Number: 001
Approval Date: Jan 7, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RYTARY (CARBIDOPA; LEVODOPA)
36.25MG;145MG
Marketing Status: Prescription
Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: RYTARY
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 36.25MG;145MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203312
Product Number: 002
Approval Date: Jan 7, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RYTARY (CARBIDOPA; LEVODOPA)
48.75MG;195MG
Marketing Status: Prescription
Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: RYTARY
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 48.75MG;195MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203312
Product Number: 003
Approval Date: Jan 7, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
RYTARY (CARBIDOPA; LEVODOPA)
61.25MG;245MG
Marketing Status: Prescription
Active Ingredient: CARBIDOPA; LEVODOPA
Proprietary Name: RYTARY
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 61.25MG;245MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203312
Product Number: 004
Approval Date: Jan 7, 2015
Applicant Holder Full Name: IMPAX LABORATORIES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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