Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207027

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PROMACTA KIT (ELTROMBOPAG OLAMINE)
EQ 12.5MG ACID/PACKET Marketing Status: Prescription

Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA KIT
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 12.5MG ACID/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207027
Product Number: 002
Approval Date: Sep 27, 2018
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

PROMACTA KIT (ELTROMBOPAG OLAMINE)
EQ 25MG ACID/PACKET Marketing Status: Prescription

Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: PROMACTA KIT
Dosage Form; Route of Administration: FOR SUSPENSION; ORAL
Strength: EQ 25MG ACID/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207027
Product Number: 001
Approval Date: Aug 24, 2015
Applicant Holder Full Name: NOVARTIS PHARMACEUTICALS CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

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