Details for New Drug Application (NDA): 207953
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NDA 207953 describes YONDELIS, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the YONDELIS profile page.
The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trabectedin profile page.
The generic ingredient in YONDELIS is trabectedin. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the trabectedin profile page.
Summary for 207953
| Tradename: | YONDELIS |
| Applicant: | Janssen Prods |
| Ingredient: | trabectedin |
| Patents: | 1 |
Pharmacology for NDA: 207953
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 207953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YONDELIS | trabectedin | POWDER;INTRAVENOUS | 207953 | NDA | Janssen Products, LP | 59676-610 | 59676-610-01 | 20 mL in 1 VIAL, SINGLE-USE (59676-610-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 1MG/VIAL | ||||
| Approval Date: | Oct 23, 2015 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 7, 2028 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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