GLYCOPYRROLATE | N210997 | EXELA PHARMA SCIENCES 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under NDA 210997, with respect to Somerset Therapeutics LLC's ANDA 207639 product for the | 505(q) | 2019-04-08 | Withdrawn | Exela Pharma Sciences |
CITIZEN PETITION FROM EXELA PHARMA SCIENCES, LLC. FDA-2018-P-4769 Exela Pharma Sciences, LLC submitted this citizen petition pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA assign a therapeutic equivalence code of "AP" in the Orange Book for GLYRX-PF (glycopyrrolate injection) in strengths of 0.2 mg/mL and 0.4 mg/2 | Other | 2018-12-17 | Withdrawn | EXELA PHARMA SCIENCES |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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