Details for New Drug Application (NDA): 215355
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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 215355
Tradename: | DECITABINE |
Applicant: | Hetero Labs Ltd Vi |
Ingredient: | decitabine |
Patents: | 0 |
Pharmacology for NDA: 215355
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 215355
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 215355 | ANDA | Camber Pharmaceuticals, Inc. | 31722-304 | 31722-304-31 | 1 VIAL, SINGLE-DOSE in 1 CARTON (31722-304-31) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL | ||||
Approval Date: | May 10, 2024 | TE: | AP | RLD: | No |
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