Details for New Drug Application (NDA): 209056
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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 209056
Tradename: | DECITABINE |
Applicant: | Wockhardt Bio Ag |
Ingredient: | decitabine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209056
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 209056
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 209056 | ANDA | Wockhardt USA LLC. | 64679-067 | 64679-067-02 | 1 VIAL, SINGLE-USE in 1 CARTON (64679-067-02) / 20 mL in 1 VIAL, SINGLE-USE (64679-067-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | Apr 9, 2019 | TE: | AP | RLD: | No |
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