BUPROPION HYDROCHLORIDE | N020358 | GLAXOSMITHKLINE
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Valeant Pharmaceuticals International, Inc. (Covington & Burling) - Citizen P... FDA-2012-P-1091 · 4 docket documents Valeant Pharmaceuticals International, Inc. filed this citizen petition on October 31, 2012, requesting that the FDA Commissioner withdraw approval of generic bupropion hydrochloride extended-release 300 mg products manufactured by Anchen (ANDA 77-284), Watson (ANDA 77-715), Actavis (ANDA 77-285), a | 505(q) | 2012-11-01 | Partially Denied | — |
Citizen Petition from Keller and Heckman LLP on behalf of Biovail Corporation FDA-2005-P-0366 · 7 docket documents Keller and Heckman LLP, on behalf of Biovail Corporation, submitted this citizen petition under 21 C.F.R. § 10.30 and section 505(j) of the FDC Act requesting that the FDA require generic versions of Wellbutrin XL (bupropion hydrochloride extended-release tablets) to meet specified bioequivalence cr | 505(q) | 2010-03-17 | Granted | Biovail Corporation |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$13.97
per ea
Lowest NADAC/Unit
$7.07
per ea
Brand NDCs
3
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00173072200WELLBUTRIN SR 200 MG TABLET | $13.97 | EA | Brand | $0.1109 | 2026-06-17 |
| 00173013555WELLBUTRIN SR 150 MG TABLET | $7.51 | EA | Brand | $0.0840 | 2026-06-17 |
| 00173094755WELLBUTRIN SR 100 MG TABLET | $7.07 | EA | Brand | $0.0752 | 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.