LEVOTHYROXINE SODIUM | A206163 | PIRAMAL CRITICAL CARE LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Amin Talati Upadhye LLP (Fera Pharmaceuticals LLC) FDA-2017-P-3950 Fera Pharmaceuticals LLC filed this citizen petition under 21 CFR § 10.30 and section 505 of the FFDCA requesting that the FDA withhold approval of InnoPharma's ANDA No. 207670 for levothyroxine injection 100 mcg/vial and 500 mcg/vial until Fera's 180-day exclusivity expires, arguing that InnoPharma | 505(q) Stay Request | 2017-06-26 | Withdrawn | Amin Talati Upadhye LLP (Fera Pharmaceuticals LLC) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.