TACROLIMUS | A065461 | SANDOZ INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Teva Pharmaceuticals (Cephalon, Inc) FDA-2015-P-1431 · 24 docket documents Teva Pharmaceuticals submitted this citizen petition under section 355(q) on behalf of its subsidiary Cephalon, requesting that FDA not approve any abbreviated new drug application for bendamustine (Treanda) referencing the chronic lymphocytic leukemia indication until expiration of the drug's orpha | 505(q) Stay Request | 2015-04-30 | Denied | Teva Pharmaceuticals (Cephalon, Inc) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.6505
per ea
Lowest NADAC/Unit
$0.1327
per ea
Brand NDCs
0
Generic NDCs
3
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00781210401TACROLIMUS 5 MG CAPSULE (IMMEDIATE RELEASE) | $0.6505 | EA | Generic | — | 2026-06-17 |
| 00781210301TACROLIMUS 1 MG CAPSULE (IMMEDIATE RELEASE) | $0.1561 | EA | Generic | — | 2026-06-17 |
| 00781210201TACROLIMUS 0.5 MG CAPSULE (IMMEDIATE RELEASE) | $0.1327 | 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.