Orange Book product · Brand (NDA)
CETROTIDE
CETRORELIX ACETATE
At a glance
Aug 11, 2000
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 2000
26 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
CETRORELIX ACETATE
Strength
EQ 0.25MG BASE/VIAL
Dosage form
POWDER
Route
SUBCUTANEOUS
TE code
AP
Application
NDA 021197
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.
- 2026CETRORELIX ACETATEGeneric (ANDA)
ANDA 218740 · EPIC PHARMA LLC
- 2025CETRORELIX ACETATEGeneric (ANDA)
ANDA 218061 · XIROMED
- 2024CETRORELIX ACETATEGeneric (ANDA)
ANDA 218150 · GLAND
- 2024CETRORELIX ACETATEGeneric (ANDA)
ANDA 214540 · LIVZON GRP
- 2024CETRORELIX ACETATEGeneric (ANDA)
ANDA 217776 · QILU
- 2022CETRORELIX ACETATEGeneric (ANDA)
ANDA 215737 · TEVA PHARMS INC
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.
