TACROLIMUS | N050708 | ASTELLAS PHARMA US INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 1 re Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0083 The provided document is an FDA Orange Book database printout showing approved drug products for tacrolimus (Prograf) in capsule form at three strengths (0.5 mg, 1 mg, and 5 mg) under NDA 050708, with orphan drug exclusivity expiring May 24, 2025. The document does not contain information about a ci | Suitability | 2021-01-26 | Open | Hyman |
Suitability Petition from Hyman, Phelps & McNamara PC FDA-2021-P-0083 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 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| ODE-360 | Jul 16, 2028 | Active |