Details for New Drug Application (NDA): 017575
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NDA 017575 describes DTIC-DOME, which is a drug marketed by Bayer Hlthcare and is included in one NDA. Additional details are available on the DTIC-DOME profile page.
The generic ingredient in DTIC-DOME is dacarbazine. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dacarbazine profile page.
The generic ingredient in DTIC-DOME is dacarbazine. There are nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dacarbazine profile page.
Summary for 017575
| Tradename: | DTIC-DOME |
| Applicant: | Bayer Hlthcare |
| Ingredient: | dacarbazine |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017575
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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