TESTOSTERONE CYPIONATE | A210362 | CIPLA LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2020-P-2133 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition pursuant to Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to file or accept any ANDA or 505(b)(2) application for levothyroxine sodium intravenous solution products unless they reference Fresenius Kabi's | 505(q) | 2020-10-28 | Denied | Fresenius Kabi USA, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$11.03
per ml
Lowest NADAC/Unit
$5.36
per ml
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 69097053731TESTOSTERONE CYP 200 MG/ML | $11.03 | ML | Generic | — | 2026-06-17 |
| 69097053637TESTOSTERONE CYP 1,000 MG/10 ML | $5.36 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.