GLYCOPYRROLATE | A040653 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 5 - Approved labelling for reference standard Glycopyrrolate Table... FDA-2022-P-1938 · 7 docket documents Suven Pharmaceuticals Limited filed a suitability petition requesting FDA recognition of Par Pharmaceutical Inc's approved labeling for Glycopyrrolate Tablets 1 mg and 2 mg (ANDA 040653) as a reference standard for use in pharmaceutical testing and manufacturing. | Suitability | 2022-08-18 | Open | Suven Pharmaceuticals Limited |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.1462
per ea
Lowest NADAC/Unit
$0.1012
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 49884006601GLYCOPYRROLATE 2 MG TABLET | $0.1462 | EA | Generic | — | 2026-06-17 |
| 49884006501GLYCOPYRROLATE 1 MG TABLET | $0.1012 | EA | 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.