ATOMOXETINE HYDROCHLORIDE | N021411 | ELI LILLY AND CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2011-05-05 | Terminated 2012-03-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Athyna Pharma, LLC FDA-2026-P-2639 Athyna Pharma, LLC filed this citizen petition under FDC Act section 505(j)(2)(C) requesting FDA approval to submit an ANDA for Atomoxetine Hydrochloride Solution, 5 mg base/mL oral liquid, which differs in dosage form and strength from the reference listed drug Eli Lilly's Strattera Capsules (NDA 0 | Suitability | 2026-03-13 | Open | Athyna Pharma |
Citizen Petition from Rosemont Pharmaceuticals Holdings, Inc. FDA-2025-P-6868 Rosemont Pharmaceuticals Holdings, Inc. filed this citizen petition requesting that the FDA determine the discontinued Strattera (atomoxetine hydrochloride) 10, 18, 25, 40, 60, 80, and 100 mg capsules (NDA 021411) from Eli Lilly and Company were not discontinued due to safety or efficacy reasons, as | 505(q) | 2025-12-09 | Withdrawn | Rosemont Pharmaceuticals Holdings |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.