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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 022571

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NDA 022571 describes CUVPOSA, which is a drug marketed by Merz Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the CUVPOSA profile page.

The generic ingredient in CUVPOSA is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

Summary for 022571

Tradename:	CUVPOSA
Applicant:	Merz Pharms
Ingredient:	glycopyrrolate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022571

Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for 022571

Adjuvants, Anesthesia
Muscarinic Antagonists

Suppliers and Packaging for NDA: 022571

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571	NDA	Merz Pharmaceuticals, LLC	0259-0501	0259-0501-16	1 BOTTLE in 1 CARTON (0259-0501-16) / 473 mL in 1 BOTTLE
CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571	NDA AUTHORIZED GENERIC	Merz Pharmaceuticals, LLC	0259-0502	0259-0502-16	1 BOTTLE in 1 CARTON (0259-0502-16) / 473 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1MG/5ML
Approval Date:	Jul 28, 2010	TE:	AA	RLD:	Yes

Expired US Patents for NDA 022571

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merz Pharms	CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571-001	Jul 28, 2010	⤷ Try a Trial	⤷ Try a Trial
Merz Pharms	CUVPOSA	glycopyrrolate	SOLUTION;ORAL	022571-001	Jul 28, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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