Orange Book product · Brand (NDA)
FACTREL
GONADORELIN HYDROCHLORIDE
Brand (NDA)NDA 018123DISCN HIKMA
At a glance
Sep 30, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 30, 1982
44 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
GONADORELIN HYDROCHLORIDE
Strength
EQ 0.5MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018123
Product number
003
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active 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.
