PARICALCITOL | A090829 | TEVA PHARMACEUTICALS USA
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Macleods Pharmaceuticals Limited FDA-2017-P-5090 Macleods Pharmaceuticals Limited filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Bionpharma Inc.'s approved ANDA number A202539 for Paricalcitol Capsule in strengths of 1 microgram, 2 microgram, and 4 microgram as a refer | 505(q) | 2017-08-22 | Denied | Macleods Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.