TRANEXAMIC ACID | A218729 | APPCO PHARMA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Appco Pharma LLC FDA-2026-P-5578 · 6 docket documents Appco Pharma LLC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Tranexamic Acid Tablets, USP 1300 mg, a new strength differing from the reference listed drug LYSTEDA (Tranexamic Acid) 650 mg tablets | Suitability | 2026-05-14 | Open | Appco Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.8854
per ea
Lowest NADAC/Unit
$0.8854
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 75907030930TRANEXAMIC ACID 650 MG TABLET | $0.8854 | EA | 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.