FDA NDA · NDA022571

CUVPOSA

glycopyrrolate

Sponsor: MERZ PHARMS

APPLICATION

NDA022571

TYPE

NDA

ORIGINAL APPROVAL

2010-07-28

LATEST ACTION

2018-02-23

ROUTE

ORAL

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

CUVPOSA · ReferencePrescription

GLYCOPYRROLATE 1MG/5ML · SOLUTION · ORAL

2018-02-23Labeling · Supplement 8 · standard — Label ↗AP

2016-05-18Labeling · Supplement 6 · standard — Label ↗AP

2016-02-08Manufacturing (CMC) · Supplement 5 · standardAP

2015-11-06Labeling · Supplement 4 · standard — Letter ↗AP

2013-05-21Labeling · Supplement 3 · standard — Label ↗AP

2012-11-08Manufacturing (CMC) · Supplement 2 · standardAP

2010-07-28Type 3 - New Dosage Form · Original · standard — Summary Review ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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