Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214120

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ONUREG (AZACITIDINE)
200MG
Marketing Status: Prescription

Active Ingredient: AZACITIDINE
Proprietary Name: ONUREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214120
Product Number: 001
Approval Date: Sep 1, 2020
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information

ONUREG (AZACITIDINE)
300MG
Marketing Status: Prescription

Active Ingredient: AZACITIDINE
Proprietary Name: ONUREG
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 300MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214120
Product Number: 002
Approval Date: Sep 1, 2020
Applicant Holder Full Name: BRISTOL MYERS SQUIBB CO
Marketing Status:  Prescription
Patent and Exclusivity Information