Orange Book product · Brand (NDA)
ZOLADEX
GOSERELIN ACETATE
Brand (NDA)NDA 020578RX TERSERA
At a glance
Jan 11, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 11, 1996
30 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
GOSERELIN ACETATE
Strength
EQ 10.8MG BASE
Dosage form
IMPLANT
Route
IMPLANTATION
TE code
Not listed
Application
NDA 020578
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
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
