GLUCAGON HYDROCHLORIDE | N201849 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Physicians Committee for Responsible Medicine FDA-2023-P-2507 · 30 docket documents The Physicians Committee for Responsible Medicine filed this citizen petition requesting that the Food and Drug Administration Commissioner require manufacturers of glucagon-like peptide-1 receptor agonists, including semaglutide, to include labeling disclosing that low-fat plant-based diets have co | Other | 2023-06-21 | Open | Physicians Committee for Responsible Medicine |
Citizen Petition for Fresenius Kabi USA, LLC FDA-2019-P-4962 · 6 docket documents Fresenius Kabi USA, LLC filed this citizen petition on October 24, 2019, requesting that the FDA designate its Glucagon for Injection, approved under 505(b)(2) NDA 201849, as therapeutically equivalent with an AP rating to the reference listed drug GlucaGen, NDA 020918, manufactured by Novo Nordisk. | Other | 2019-10-24 | Withdrawn | — |
Citizen Petition from Cornerstone Regulatory FDA-2007-P-0248 · 6 docket documents Cornerstone Regulatory submitted this citizen petition requesting that the FDA determine whether Eli Lilly's decision to discontinue marketing Glucagon Hydrochloride for Injection (NDA 12-122) was for reasons of safety or effectiveness, and if not, declare the product suitable for submission as an a | Other | 2008-05-14 | Denied | Cornerstone Regulatory |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$239.27
per ea
Lowest NADAC/Unit
$239.27
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63323058282GLUCAGON 1 MG EMERGENCY KIT | $239.27 | EA | Brand | — | 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.