Details for New Drug Application (NDA): 208485
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NDA 208485 describes CYTARABINE, which is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Norvium Bioscience, Rising, Teva Parenteral, and West-ward Pharms Int, and is included in nineteen NDAs. It is available from five suppliers. Additional details are available on the CYTARABINE profile page.
The generic ingredient in CYTARABINE is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.
The generic ingredient in CYTARABINE is cytarabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the cytarabine profile page.
Summary for 208485
| Tradename: | CYTARABINE |
| Applicant: | Meitheal |
| Ingredient: | cytarabine |
| Patents: | 0 |
Pharmacology for NDA: 208485
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 208485
Suppliers and Packaging for NDA: 208485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYTARABINE | cytarabine | INJECTABLE;INJECTION | 208485 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-169 | 71288-169-25 | 1 VIAL, MULTI-DOSE in 1 CARTON (71288-169-25) / 25 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Feb 28, 2022 | TE: | AP | RLD: | No | ||||
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