Details for New Drug Application (NDA): 214486
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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 214486
Tradename: | DECITABINE |
Applicant: | Zydus Pharms |
Ingredient: | decitabine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 214486
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 214486
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 214486 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1656 | 70710-1656-1 | 1 VIAL in 1 CARTON (70710-1656-1) / 20 mL in 1 VIAL |
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 214486 | ANDA | Zydus Lifesciences Limited | 70771-1713 | 70771-1713-1 | 1 VIAL in 1 CARTON (70771-1713-1) / 20 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | Nov 19, 2021 | TE: | AP | RLD: | No |
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