Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 216201

Expand all

NITISINONE (NITISINONE)
2MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: NITISINONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216201
Product Number: 001
Approval Date: May 25, 2023
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NITISINONE (NITISINONE)
5MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: NITISINONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216201
Product Number: 002
Approval Date: May 25, 2023
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NITISINONE (NITISINONE)
10MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: NITISINONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216201
Product Number: 003
Approval Date: May 25, 2023
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NITISINONE (NITISINONE)
20MG
Marketing Status: Prescription

Active Ingredient: NITISINONE
Proprietary Name: NITISINONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216201
Product Number: 004
Approval Date: May 25, 2023
Applicant Holder Full Name: ETON PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information