GANIRELIX ACETATE | A204246 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Sun Pharmaceutical Industries, Ltd. (Winston & Strawn LLP) - Citizen Petition FDA-2013-P-1292 · 3 docket documents Sun Pharmaceutical Industries Ltd. filed this citizen petition requesting FDA confirmation that Ganirelix Acetate Injection has not been approved for use as a female contraceptive and that its FDA-labeled indication for inhibiting premature LH surges in women undergoing controlled ovarian hyperstimu | 505(q) | 2013-11-14 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$62.35
per ml
Lowest NADAC/Unit
$62.35
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 55566101001FYREMADEL 250 MCG/0.5 ML SYR | $62.35 | ML | Generic | — | 2025-12-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.