U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 206788

Expand all

ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE)
EQ 12.5MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: ELTROMBOPAG OLAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 12.5MG ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206788
Product Number: 001
Approval Date: Jan 17, 2025
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:  Prescription
Patent and Exclusivity Information
ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE)
EQ 25MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: ELTROMBOPAG OLAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 25MG ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206788
Product Number: 002
Approval Date: Jan 17, 2025
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:  Prescription
Patent and Exclusivity Information
ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE)
EQ 50MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: ELTROMBOPAG OLAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206788
Product Number: 003
Approval Date: Jan 17, 2025
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:  Prescription
Patent and Exclusivity Information
ELTROMBOPAG OLAMINE (ELTROMBOPAG OLAMINE)
EQ 75MG ACID
Marketing Status: Prescription
Active Ingredient: ELTROMBOPAG OLAMINE
Proprietary Name: ELTROMBOPAG OLAMINE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 75MG ACID
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A206788
Product Number: 004
Approval Date: Jan 17, 2025
Applicant Holder Full Name: HETERO LABS LTD UNIT V
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top