Orange Book product · Brand (NDA)
GANIRELIX ACETATE
GANIRELIX ACETATE
At a glance
Jul 29, 1999
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 29, 1999
27 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
GANIRELIX ACETATE
Strength
250MCG/0.5ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 021057
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.
- 2025GANIRELIX ACETATEGeneric (ANDA)
ANDA 219454 · TRIS PHARMA INC
- 2025GANIRELIX ACETATEGeneric (ANDA)
ANDA 218855 · QILU
- 2023GANIRELIX ACETATEGeneric (ANDA)
ANDA 216075 · LUPIN
- 2023GANIRELIX ACETATEGeneric (ANDA)
ANDA 215658 · GLAND
- 2022GANIRELIX ACETATEGeneric (ANDA)
ANDA 214996 · MEITHEAL
- 2022GANIRELIX ACETATEGeneric (ANDA)
ANDA 212613 · AMPHASTAR PHARMS INC
- 2018FYREMADELGeneric (ANDA)
ANDA 204246 · SUN PHARM
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.
