Details for New Drug Application (NDA): 205539
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NDA 205539 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Jiangsu Hansoh Pharm, Lupin Ltd, Meitheal, MSN, Nivagen Pharms Inc, Novast Labs, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty NDAs. It is available from twenty-four suppliers. Additional details are available on the DECITABINE profile page.
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.
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 205539
| Tradename: | DECITABINE |
| Applicant: | Gland |
| Ingredient: | decitabine |
| Patents: | 0 |
Pharmacology for NDA: 205539
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors |
Suppliers and Packaging for NDA: 205539
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 205539 | ANDA | Sagent Pharmaceuticals | 25021-231 | 25021-231-20 | 1 VIAL in 1 CARTON (25021-231-20) / 10 mL in 1 VIAL |
| DECITABINE | decitabine | INJECTABLE;INTRAVENOUS | 205539 | ANDA | Gland Pharma Limited | 68083-528 | 68083-528-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-528-01) / 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: | Nov 23, 2020 | TE: | AP | RLD: | No | ||||
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