ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | A090485 | AMNEAL PHARMACEUTICALS
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-5984 · 7 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Tramadol Hydrochloride and Acetaminophen Tablet 300mg; 25mg suitable for submission in an ANDA, differing in strength from the re | Suitability | 2026-05-27 | Open | Senores Pharmaceuticals, Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1054
per ea
Lowest NADAC/Unit
$0.1054
per ea
Brand NDCs
0
Generic NDCs
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 53746061701TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | $0.1054 | EA | Generic | — | 2026-06-17 |
| 53746061705TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | $0.1054 | EA | Generic | — | 2026-06-17 |
| 53746061710TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | $0.1054 | EA | Generic | — | 2026-06-17 |
| 50268077415TRAMADOL-ACETAMINOPHEN 37.5-325 MG TAB | $0.1054 | 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.