BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE | A201633 | SUN PHARMACEUTICAL INDUSTRIES LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Lachman Consultant Sevices, Inc.- Citizen Petition FDA-2012-P-1034 · 5 docket documents Lachman Consultant Services, Inc., on behalf of a client, filed this citizen petition requesting that the FDA determine whether SUBOXONE Sublingual Tablets (buprenorphine hydrochloride and naloxone hydrochloride) 2 mg/0.5 mg and 8 mg/2 mg, approved under NDA 20-733, were voluntarily withdrawn from s | 505(q) | 2012-10-01 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.6695
per ea
Lowest NADAC/Unit
$0.4123
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 62756097083BUPRENORPHINE-NALOXONE 8-2 MG SL TABLET | $0.6695 | EA | Generic | — | 2026-06-17 |
| 62756096983BUPRENORPHINE-NALOXONE 2-0.5 MG SL TABLET | $0.4123 | 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.