Orange Book product · Brand (NDA)
LUPRON
LEUPROLIDE ACETATE
At a glance
Apr 09, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 09, 1985
41 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
LEUPROLIDE ACETATE
Strength
14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 019010
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 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.
