TRIAMCINOLONE ACETONIDE | N012041 | APOTHECON INC DIV BRISTOL MYERS SQUIBB
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AuroMedics Pharma LLC FDA-2018-P-3599 AuroMedics Pharma LLC, the U.S. agent for Aurobindo Pharma Limited, filed this petition requesting that FDA determine the original formulation of NDA 012041 for Kenalog-10 (Triamcinolone Acetonide Injectable Suspension, USP 10 mg per mL) was not discontinued for safety or efficacy reasons and may be | 505(q) | 2018-09-25 | Granted | AuroMedics Pharma LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.
KENALOG-10 (triamcinolone acetonide) by Apothecon no longer carries a reportable supply status designation in the Orange Book.
Old: Yes
New: No