Details for New Drug Application (NDA): 203475
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The generic ingredient in DECITABINE is decitabine. There are eighteen drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 203475
Tradename: | DECITABINE |
Applicant: | Accord Hlthcare |
Ingredient: | decitabine |
Patents: | 0 |
Pharmacology for NDA: 203475
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 203475
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 203475 | ANDA | Accord Healthcare Inc. | 16729-224 | 16729-224-05 | 1 VIAL in 1 CARTON (16729-224-05) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | Feb 27, 2017 | TE: | AP | RLD: | No |
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