Details for New Drug Application (NDA): 021790
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NDA 021790 describes DACOGEN, which is a drug marketed by Otsuka and is included in one NDA. Additional details are available on the DACOGEN profile page.
The generic ingredient in DACOGEN 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 DACOGEN 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 021790
| Tradename: | DACOGEN |
| Applicant: | Otsuka |
| Ingredient: | decitabine |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 2, 2006 | TE: | RLD: | Yes | |||||
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