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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. There are two patents protecting this drug and one Paragraph IV challenge. 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. Forty-four suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.
The generic ingredient in CUVPOSA is glycopyrrolate. There are seventeen drug master file entries for this compound. Forty-four 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: | 2 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022571
| Mechanism of Action | Cholinergic Antagonists |
Medical Subject Heading (MeSH) Categories for 022571
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 |
Paragraph IV (Patent) Challenges for 022571
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| CUVPOSA | SOLUTION;ORAL | glycopyrrolate | 022571 | 2012-06-20 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/5ML | ||||
| Approval Date: | Jul 28, 2010 | TE: | RLD: | Yes | |||||
| Patent: | Start Trial | Patent Expiration: | Aug 20, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA)IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING | ||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 20, 2023 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA)IN PATIENTS WITH NEUROLOGIC CONDITIONS ASSOCIATED WITH PROBLEM DROOLING | ||||||||
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