BACLOFEN | A072235 | IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara, PC FDA-2020-P-2067 · 6 docket documents The law firm Hyman, Phelps & McNamara, P.C., filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 to request that the FDA declare Baclofen Tablets, 15 mg, suitable for submission in an Abbreviated New Drug | Suitability | 2020-10-13 | Granted | Hyman, Phelps & McNamara, PC |
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
$0.0552
per ea
Lowest NADAC/Unit
$0.0552
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00172409760BACLOFEN 20 MG TABLET | $0.0552 | EA | Generic | — | 2026-06-17 |
| 00172409780BACLOFEN 20 MG TABLET | $0.0552 | 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.