Details for New Drug Application (NDA): 214120
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NDA 214120 describes ONUREG, which is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the ONUREG profile page.
The generic ingredient in ONUREG is azacitidine. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
The generic ingredient in ONUREG is azacitidine. There are fifteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 214120
| Tradename: | ONUREG |
| Applicant: | Bristol |
| Ingredient: | azacitidine |
| Patents: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214120
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 214120
Suppliers and Packaging for NDA: 214120
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONUREG | azacitidine | TABLET;ORAL | 214120 | NDA | Celgene Corporation | 59572-730 | 59572-730-07 | 7 TABLET, FILM COATED in 1 BLISTER PACK (59572-730-07) |
| ONUREG | azacitidine | TABLET;ORAL | 214120 | NDA | Celgene Corporation | 59572-730 | 59572-730-14 | 14 TABLET, FILM COATED in 1 BOTTLE (59572-730-14) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Sep 1, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 1, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 14, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 3, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY | ||||||||
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