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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022291

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PROMACTA (ELTROMBOPAG OLAMINE)
EQ 12.5MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG ACID
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022291
Product Number: 004
Approval Date: Oct 20, 2011
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
PROMACTA (ELTROMBOPAG OLAMINE)
EQ 25MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG ACID
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022291
Product Number: 001
Approval Date: Nov 20, 2008
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
PROMACTA (ELTROMBOPAG OLAMINE)
EQ 50MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG ACID
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022291
Product Number: 002
Approval Date: Nov 20, 2008
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
PROMACTA (ELTROMBOPAG OLAMINE)
EQ 75MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG ACID
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022291
Product Number: 003
Approval Date: Sep 8, 2009
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information
PROMACTA (ELTROMBOPAG OLAMINE)
EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 100MG ACID **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: N022291
Product Number: 005
Approval Date: Nov 16, 2012
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Discontinued
Patent and Exclusivity Information
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