Orange Book product · Generic (ANDA)
LEUPROLIDE ACETATE
LEUPROLIDE ACETATE
At a glance
Nov 13, 2025
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 13, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
LEUPROLIDE ACETATE
Strength
14MG/2.8ML (1MG/0.2ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
AP
Application
ANDA 215826
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LEUPROLIDE ACETATE
- 2020FENSOLVI KITBrand (NDA)
NDA 213150 · TOLMAR
- 2018LEUPROLIDE ACETATE FOR DEPOT SUSPENSIONBrand (NDA)
NDA 205054 · INVAGEN PHARMS
- 2004ELIGARD KITBrand (NDA)
NDA 021731 · TOLMAR
- 2003ELIGARD KITBrand (NDA)
NDA 021488 · TOLMAR
- 2002ELIGARD KITBrand (NDA)
NDA 021379 · TOLMAR
- 2002ELIGARD KITBrand (NDA)
NDA 021343 · TOLMAR
- 2000VIADURBrand (NDA)
NDA 021088 · ORTHO MCNEIL JANSSEN
- 1997LUPRON DEPOTBrand (NDA)
NDA 020708 · ABBVIE ENDOCRINE INC
- 1995LUPRON DEPOTBrand (NDA)
NDA 020517 · ABBVIE ENDOCRINE INC
- 1993LUPRON DEPOT-PED KITBrand (NDA)
NDA 020263 · ABBVIE ENDOCRINE INC
- 1990LUPRON DEPOTBrand (NDA)
NDA 020011 · ABBVIE ENDOCRINE INC
- 1989LUPRON DEPOTBrand (NDA)
NDA 019732 · ABBVIE ENDOCRINE 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.
