Details for New Drug Application (NDA): 208485
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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 |
Formulation / Manufacturing: | see details |
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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