Orange Book product · Brand (NDA)
YONDELIS
TRABECTEDIN
Brand (NDA)NDA 207953RX JANSSEN PRODS
At a glance
Oct 23, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 23, 2015
10 yr 10 mo ago
Today
Patent 8895557 expires
Listed drug product patent expiration.
Jan 07, 2028
in 1 yr 7 mo
Patent 8895557*PED expires
Listed listed patent expiration.
Jul 07, 2028
in 2 yr 1 mo
Pharmaceutical detail
Active ingredient
TRABECTEDIN
Strength
1MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 207953
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8895557 | Jan 07, 2028 | in 1 yr 7 mo | Product |
| 8895557*PED | Jul 07, 2028 | in 2 yr 1 mo |
