CARBAMAZEPINE | A205571 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Axinn on behalf of Zydus Pharmaceuticals (USA) Inc. FDA-2019-P-3545 · 7 docket documents Axinn, on behalf of Zydus Pharmaceuticals (USA) Inc., filed this citizen petition under Section 505 of the FD&C Act requesting that FDA require pending and approved abbreviated new drug applications for Carbamazepine Extended Release Tablets referencing Tegretol XR to comply with the March 2015 prod | 505(q) | 2019-07-26 | Denied | Zydus Pharmaceuticals (USA) Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.6070
per ea
Lowest NADAC/Unit
$0.2239
per ea
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 16714006501CARBAMAZEPINE ER 400 MG TABLET | $0.6070 | EA | Generic | — | 2026-06-17 |
| 68382055701CARBAMAZEPINE ER 400 MG TABLET | $0.6070 | EA | Generic | — | 2026-06-17 |
| 16714006401CARBAMAZEPINE ER 200 MG TABLET | $0.3488 | EA | Generic | — | 2026-06-17 |
| 68382055601CARBAMAZEPINE ER 200 MG TABLET | $0.3488 | EA | Generic | — | 2026-06-17 |
| 16714006301CARBAMAZEPINE ER 100 MG TABLET | $0.2239 | EA | Generic | — | 2026-06-17 |
| 68382055501CARBAMAZEPINE ER 100 MG TABLET | $0.2239 | 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.