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 under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Tramadol Hydrochloride and Acetaminophen Tablet at proposed strengths of 300 mg and 25 mg, wh | 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.