EPINEPHRINE | N016803 | STERLING HEALTH DIV STERLING WINTHROP INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Arnall Golden Gregory, LLP FDA-2025-P-4612 · 3 docket documents Arnall Golden Gregory LLP, on behalf of ARS Pharmaceuticals Inc., filed this citizen petition on October 1, 2025, requesting that FDA refrain from approving Aquestive Therapeutics' 505(b)(2) New Drug Application for AQST-109 Epinephrine Sublingual Film (Anaphylm) without conducting additional real-w | 505(q) | 2025-10-02 | Denied | Arnall Golden Gregory, LLP |
Citizen Petition From Mylan Specialty, L.P. FDA-2015-P-0181 · 9 docket documents Mylan Specialty, L.P. filed this citizen petition on January 16, 2015, under 21 USC 355 and 21 CFR 10.30, requesting that the FDA refrain from approving Teva Pharmaceuticals' ANDA 90-589 for an epinephrine auto-injector referencing EpiPen® as the reference listed drug, unless the agency determines t | 505(q) | 2015-01-20 | Denied | Mylan Specialty, L.P. |
Arent Fox, LLP - Citizen Petition FDA-2010-P-0072 · 7 docket documents Arent Fox, LLP filed this suitability petition under Section 505(j)(2)(C) of the Food, Drug, and Cosmetic Act requesting that the FDA declare a new dosage form of Lidocaine Hydrochloride 2% and Epinephrine 1:200,000 Injection in a 1.7 mL dental cartridge suitable for submission via Abbreviated New D | Other | 2010-02-03 | Withdrawn | — |
Dey Pharma, L.P. - Citizen Petition FDA-2009-P-0578 · 6 docket documents Dey Pharma, L.P., the distributor of EpiPen (epinephrine) Auto-Injector, filed this citizen petition under Section 505(q) of the Federal Food, Drug and Cosmetic Act requesting that the FDA decline to approve or assign an "AB" rating to any proposed generic ANDA for EpiPen auto-injectors unless they | 505(q) | 2009-12-07 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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