Details for New Drug Application (NDA): 212265
✉ Email this page to a colleague
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 212265
Tradename: | DECITABINE |
Applicant: | Msn |
Ingredient: | decitabine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 212265
Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 212265
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 212265 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-115 | 69539-115-01 | 1 VIAL, SINGLE-USE in 1 CARTON (69539-115-01) / 20 mL in 1 VIAL, SINGLE-USE |
DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 212265 | ANDA | Novadoz Pharmaceuticals LLC | 72205-031 | 72205-031-01 | 1 VIAL, SINGLE-USE in 1 CARTON (72205-031-01) / 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: | Aug 28, 2019 | TE: | AP | RLD: | No |
Complete Access Available with Subscription