FDA Orange Book
Is there a generic for Synarel?
Synarel contains nafarelin acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Synarel (nafarelin acetate).
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Synarel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| spray, metered, nasal | EQ 0.2MG BASE/SPRAY | Marketed (Rx) | None | 0 | None |
NDA 019886, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Synarel NDC codes
Questions
Is there a generic for Synarel?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Synarel (nafarelin acetate).
What is the generic name for Synarel?
The active ingredient in Synarel is nafarelin acetate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.