Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216774

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ALVAIZ (ELTROMBOPAG CHOLINE)
EQ 9MG BASE
Marketing Status: Prescription

Active Ingredient: ELTROMBOPAG CHOLINE
Proprietary Name: ALVAIZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 9MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216774
Product Number: 001
Approval Date: Nov 29, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALVAIZ (ELTROMBOPAG CHOLINE)
EQ 18MG BASE
Marketing Status: Prescription

Active Ingredient: ELTROMBOPAG CHOLINE
Proprietary Name: ALVAIZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 18MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216774
Product Number: 002
Approval Date: Nov 29, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALVAIZ (ELTROMBOPAG CHOLINE)
EQ 36MG BASE
Marketing Status: Prescription

Active Ingredient: ELTROMBOPAG CHOLINE
Proprietary Name: ALVAIZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 36MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216774
Product Number: 003
Approval Date: Nov 29, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ALVAIZ (ELTROMBOPAG CHOLINE)
EQ 54MG BASE
Marketing Status: Prescription

Active Ingredient: ELTROMBOPAG CHOLINE
Proprietary Name: ALVAIZ
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 54MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216774
Product Number: 004
Approval Date: Nov 29, 2023
Applicant Holder Full Name: TEVA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information