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 a suitability petition requesting that the FDA establish that a drug substance is suitable for use as an active pharmaceutical ingredient in an NDA formulation, specifically for use in developing a new drug product that would be manufactured and distributed by Appco Pharma. | Suitability | 2026-05-14 | Open | Appco Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.8567
per ea
Lowest NADAC/Unit
$0.8567
per ea
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 75907030930TRANEXAMIC ACID 650 MG TABLET | $0.8567 | EA | Generic | — | 2026-08-19 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.