Details for New Drug Application (NDA): 217453
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NDA 217453 describes AZACITIDINE, which is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal, Cipla, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, Msn Labs Pvt Ltd, Natco Pharma Ltd, Norvium Bioscience, Reliance Life, and Shilpa Medicare, and is included in sixteen NDAs. It is available from twenty-one suppliers. Additional details are available on the AZACITIDINE profile page.
The generic ingredient in AZACITIDINE is azacitidine. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
The generic ingredient in AZACITIDINE is azacitidine. There are fifteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 217453
| Tradename: | AZACITIDINE |
| Applicant: | Reliance Life |
| Ingredient: | azacitidine |
| Patents: | 0 |
Pharmacology for NDA: 217453
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 217453
Suppliers and Packaging for NDA: 217453
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 217453 | ANDA | Reliance Life Sciences Private Limited | 58458-002 | 58458-002-02 | 1 VIAL, GLASS in 1 CARTON (58458-002-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
| AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 217453 | ANDA | Somerset Therapeutics LLC | 70069-857 | 70069-857-01 | 1 VIAL, GLASS in 1 CARTON (70069-857-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, SUBCUTANEOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | May 20, 2025 | TE: | AP | RLD: | No | ||||
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