Details for New Drug Application (NDA): 206033
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The generic ingredient in DECITABINE is decitabine. There are eighteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 206033
| Tradename: | DECITABINE |
| Applicant: | Chemi Spa |
| Ingredient: | decitabine |
| Patents: | 0 |
Pharmacology for NDA: 206033
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 206033
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 206033 | ANDA | Amneal Pharmaceuticals LLC | 70121-1644 | 70121-1644-1 | 1 VIAL, SINGLE-USE in 1 CARTON (70121-1644-1) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
| Approval Date: | Sep 22, 2017 | TE: | AP | RLD: | No | ||||
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