GLYCOPYRROLATE | A040653 | PH HEALTH LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Attachment 5 - Approved labelling for reference standard Glycopyrrolate Table... FDA-2022-P-1938 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.
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