Details for New Drug Application (NDA): 050682
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NDA 050682 describes COSMEGEN, which is a drug marketed by Recordati Rare and is included in one NDA. Additional details are available on the COSMEGEN profile page.
The generic ingredient in COSMEGEN is dactinomycin. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
The generic ingredient in COSMEGEN is dactinomycin. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
Summary for 050682
| Tradename: | COSMEGEN |
| Applicant: | Recordati Rare |
| Ingredient: | dactinomycin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 050682
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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