FDA Orange Book · active-ingredient family
Histrelin acetate
Histrelin acetate is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SUPPRELIN LA · NDA 022058
3
Brand (NDA)
0
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · implant, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUPPRELIN LARLD | ENDO OPERATIONS | NDA 022058 | — | May 03, 2007 | |
| VANTASRLD | ENDO OPERATIONS | NDA 021732 | — | Oct 12, 2004 | |
| SUPPRELIN×3 | SHIRE | NDA 019836 | — | Dec 24, 1991 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8062652 | Jun 16, 2026 | 3 d ago | U-1197 |
Histrelin acetate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
