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Details for New Drug Application (NDA): 022571
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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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