BUPRENORPHINE HYDROCHLORIDE | A078633 | HIKMA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
E. Douglas Kramer and Nabarun Dasgupta - Citizen Petition FDA-2009-P-0154 · 4 docket documents E. Douglas Kramer, MD and Nabarun Dasgupta, MPH filed this citizen petition requesting that FDA conduct a safety review of all pending, approved, or tentatively approved Abbreviated New Drug Applications for which Subutex (buprenorphine) or Suboxone (buprenorphine plus naloxone) is the reference lis | 505(q) | 2009-03-24 | Denied | — |
E. Douglas Kramer - Citizen Petition FDA-2009-P-0074 · 3 docket documents E. Douglas Kramer, MD, and Nabarun Dasgupta, MPH, filed this citizen petition under 21 CFR 10.30 requesting that the FDA approve only those Abbreviated New Drug Applications (ANDAs) for which Subutex (buprenorphine) or Suboxone (buprenorphine plus naloxone) is the Reference Listed Drug if the inacti | 505(q) | 2009-02-19 | Withdrawn | — |
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
4
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00054017713BUPRENORPHINE 8 MG TABLET SL | $0.5616 | EA | Generic | — | 2026-06-17 |
| 00904715504BUPRENORPHINE 8 MG TABLET SL | $0.5616 | EA | Generic | — | 2026-06-17 |
| 00054017613BUPRENORPHINE 2 MG TABLET SL | $0.2629 | EA | Generic | — | 2026-06-17 |
| 00904715404BUPRENORPHINE 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.