TACROLIMUS | N050708 | ASTELLAS PHARMA US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0083 · 6 docket documents On January 14, 2021, Hyman, Phelps & McNamara PC filed a suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93, requesting that the FDA declare Tacrolimus Capsules in 0.25 mg, 0.75 mg, 2 mg, and 3 mg strengths su | Suitability | 2021-01-26 | Granted | Hyman, Phelps & McNamara PC |
Ascend Laboratories, LLC - Citizen Petition FDA-2013-P-0767 · 3 docket documents Ascend Laboratories, LLC submitted this citizen petition on June 13, 2013, requesting that the FDA determine the suitability of Tacrolimus Oral Suspension as an additional dosage form to NDA 050708 for PROGRAF (tacrolimus), which is currently approved only as capsules and injection solution for orga | Other | 2013-07-02 | Open | — |
Astellas Pharma US, Inc. - Citizen Petition FDA-2007-P-0111 · 11 docket documents Astellas Pharma US, Inc., the NDA holder for Prograf (tacrolimus), filed this petition under section 505(b) and (j) of the FDCA requesting that the FDA require bioequivalence studies in transplant patients for orally administered narrow therapeutic index immunosuppressants, mandate specific labeling | 505(q) | 2008-05-23 | Partially Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$7.33
per ea
Lowest NADAC/Unit
$3.66
per ea
Brand NDCs
2
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00469061773PROGRAF 1 MG CAPSULE | $7.33 | EA | Brand | $0.1561 | 2026-06-17 |
| 00469060773PROGRAF 0.5 MG CAPSULE | $3.66 | EA | Brand | $0.1327 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| ODE-360 | Jul 16, 2028 | Active |