BACLOFEN | A072234 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 - FDA Electronic Orange Book printout for Baclofen products Labe... FDA-2019-P-3423 · 3 docket documents Oxford Pharmaceuticals LLC filed this petition regarding baclofen tablets, specifically requesting clarification on the suitability of the Ivax/Teva baclofen tablet formulation for bioequivalence purposes under the abbreviated new drug application pathway. | Suitability | 2019-07-17 | Open | Oxford Pharmaceuticals LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0332
per ea
Lowest NADAC/Unit
$0.0332
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00172409660BACLOFEN 10 MG TABLET | $0.0332 | EA | Generic | — | 2026-06-17 |
| 00172409680BACLOFEN 10 MG TABLET | $0.0332 | 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.