Details for New Drug Application (NDA): 207518
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NDA 207518 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, and Shilpa Medicare, and is included in fifteen NDAs. It is available from seventeen 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. Eighteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the azacitidine profile page.
Summary for 207518
| Tradename: | AZACITIDINE |
| Applicant: | Shilpa Medicare |
| Ingredient: | azacitidine |
| Patents: | 0 |
Pharmacology for NDA: 207518
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 207518
Suppliers and Packaging for NDA: 207518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 207518 | ANDA | Dr. Reddy's Laboratories Inc. | 43598-678 | 43598-678-11 | 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (43598-678-11) |
| AZACITIDINE | azacitidine | POWDER;INTRAVENOUS, SUBCUTANEOUS | 207518 | ANDA | Fresenius Kabi USA, LLC | 63323-771 | 63323-771-39 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-771-39) / 30 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS, SUBCUTANEOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Sep 29, 2016 | TE: | AP | RLD: | No | ||||
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