HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM | A201682 | IPCA LABORATORIES LTD
| 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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