GLYCOPYRROLATE | A207639 | SOMERSET THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Exela Pharma Sciences, LLC. FDA-2019-P-1678 Exela Pharma Sciences, LLC filed this citizen petition requesting that the FDA assign a therapeutic equivalence code of "AP" to GLYRX-PF (glycopyrrolate injection) 0.2 mg/mL and 0.4 mg/2 mL, which was approved under NDA 210997, with respect to Somerset Therapeutics LLC's ANDA 207639 product for the | 505(q) | 2019-04-08 | Withdrawn | Exela Pharma Sciences |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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