Details for New Drug Application (NDA): 050794
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NDA 050794 describes VIDAZA, which is a drug marketed by Bristol-myers and is included in one NDA. It is available from two suppliers. Additional details are available on the VIDAZA profile page.
The generic ingredient in VIDAZA 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 VIDAZA 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 050794
| Tradename: | VIDAZA |
| Applicant: | Bristol-myers |
| Ingredient: | azacitidine |
| Patents: | 0 |
Pharmacology for NDA: 050794
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 050794
Suppliers and Packaging for NDA: 050794
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIDAZA | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 050794 | NDA AUTHORIZED GENERIC | Sandoz Inc | 0781-3253 | 0781-3253-94 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3253-94) |
| VIDAZA | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 050794 | NDA | Celgene Corporation | 59572-102 | 59572-102-01 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (59572-102-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, SUBCUTANEOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | May 19, 2004 | TE: | AP | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | May 20, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) | ||||||||
| Regulatory Exclusivity Expiration: | May 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML) | ||||||||
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