Details for New Drug Application (NDA): 205582
NDA 205582 describes DECITABINE, which is a drug marketed by Accord Hlthcare, Chemi Spa, Cipla, Dr Reddys, Eugia Pharma, Gland, Hetero Labs Ltd Vi, Ingenus Pharms Llc, Jiangsu Hansoh Pharm, Lupin, Meitheal, MSN, Nivagen, Pharmascience Inc, Qilu Pharm Hainan, Sagent Pharms Inc, Sandoz, Somerset Theraps Llc, Wockhardt Bio Ag, Zydus Pharms, and Sun Pharm, and is included in twenty-one NDAs. It is available from eighteen suppliers. Additional details are available on the DECITABINE profile page.
The generic ingredient in DECITABINE is decitabine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.
The generic ingredient in DECITABINE is decitabine. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the decitabine profile page.
Summary for 205582
| Tradename: | DECITABINE |
| Applicant: | Sun Pharm |
| Ingredient: | decitabine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205582
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DECITABINE | decitabine | POWDER;INTRAVENOUS | 205582 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-361 | 47335-361-41 | 1 KIT in 1 CARTON (47335-361-41) * 10 mL in 1 VIAL, SINGLE-DOSE * 10 mL in 1 VIAL (47335-362-40) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | 50MG/VIAL | ||||
| Approval Date: | Jan 28, 2014 | TE: | RLD: | Yes | |||||
Complete Access Available with Subscription
