GLYCOPYRROLATE | A207639 | SOMERSET THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Exela Pharma Sciences, LLC. FDA-2019-P-1678 · 4 docket documents 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under NDA 210997, with respect to Somerset Therapeutics LLC's ANDA 207639 product for the | 505(q) | 2019-04-08 | Withdrawn | Exela Pharma Sciences, LLC. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$1.33
per ml
Lowest NADAC/Unit
$1.33
per ml
Brand NDCs
0
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70069061725GLYCOPYRROLATE 0.2 MG/ML VIAL | $1.33 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.