BUPRENORPHINE HYDROCHLORIDE | A090819 | ACTAVIS ELIZABETH LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Actavis Elizabeth LLC - Citizen Petition FDA-2013-P-1055 · 5 docket documents Actavis Elizabeth LLC filed this citizen petition on August 16, 2013, requesting that the FDA determine whether SUBUTEX (buprenorphine hydrochloride) sublingual tablets in 2 mg and 8 mg base strengths, originally approved under NDA 20-732, were voluntarily withdrawn from the market for safety or eff | 505(q) | 2013-09-16 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.5616
per ea
Lowest NADAC/Unit
$0.2629
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00228315303BUPRENORPHINE 8 MG TABLET SL | $0.5616 | EA | Generic | — | 2026-06-17 |
| 00228315603BUPRENORPHINE 2 MG TABLET SL | $0.2629 | 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.