Details for New Drug Application (NDA): 212128
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NDA 212128 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, Pharmobedient, Reliance Life, and Shilpa Medicare, and is included in sixteen NDAs. It is available from twenty 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-one 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-one suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 212128
| Tradename: | AZACITIDINE |
| Applicant: | Meitheal |
| Ingredient: | azacitidine |
| Patents: | 0 |
Pharmacology for NDA: 212128
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 212128
Suppliers and Packaging for NDA: 212128
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 212128 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-115 | 71288-115-30 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-115-30) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
| AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 212128 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-153 | 71288-153-95 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-153-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, SUBCUTANEOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Nov 2, 2020 | TE: | AP | RLD: | No | ||||
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