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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207947

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UPTRAVI (SELEXIPAG)
0.2MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207947
Product Number: 001
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
0.4MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.4MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N207947
Product Number: 002
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
0.6MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207947
Product Number: 003
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
0.8MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.8MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207947
Product Number: 004
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
1MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207947
Product Number: 005
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
1.2MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.2MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207947
Product Number: 006
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
1.4MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.4MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207947
Product Number: 007
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
UPTRAVI (SELEXIPAG)
1.6MG
Marketing Status: Prescription
Active Ingredient: SELEXIPAG
Proprietary Name: UPTRAVI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N207947
Product Number: 008
Approval Date: Dec 21, 2015
Applicant Holder Full Name: ACTELION PHARMACEUTICALS US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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