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. It is available from two suppliers. 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. Six 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. Six 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 |
Pharmacology for NDA: 050682
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for 050682
Suppliers and Packaging for NDA: 050682
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| COSMEGEN | dactinomycin | INJECTABLE;INJECTION | 050682 | NDA | Recordati Rare Diseases, Inc. | 55292-811 | 55292-811-55 | 12 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) / 1 mL in 1 VIAL, SINGLE-DOSE |
| COSMEGEN | dactinomycin | INJECTABLE;INJECTION | 050682 | NDA AUTHORIZED GENERIC | Prasco Laboratories | 66993-489 | 66993-489-35 | 12 CARTON in 1 CARTON (66993-489-35) / 1 VIAL, SINGLE-DOSE in 1 CARTON (66993-489-83) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 0.5MG/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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