Details for New Drug Application (NDA): 076512
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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 076512
Tradename: | CYTARABINE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | cytarabine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076512
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 076512
Suppliers and Packaging for NDA: 076512
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
CYTARABINE | cytarabine | INJECTABLE;INJECTION | 076512 | ANDA | Fresenius Kabi USA, LLC | 63323-120 | 63323-120-20 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-120-20) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/ML | ||||
Approval Date: | Jan 15, 2004 | TE: | AP | RLD: | No |
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