Details for New Drug Application (NDA): 216903
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NDA 216903 describes PREVDUO, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the PREVDUO profile page.
The generic ingredient in PREVDUO is glycopyrrolate; neostigmine methylsulfate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrrolate; neostigmine methylsulfate profile page.
The generic ingredient in PREVDUO is glycopyrrolate; neostigmine methylsulfate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the glycopyrrolate; neostigmine methylsulfate profile page.
Summary for 216903
| Tradename: | PREVDUO |
| Applicant: | Azurity |
| Ingredient: | glycopyrrolate; neostigmine methylsulfate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216903
Generic Entry Date for 216903*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 216903
| Mechanism of Action | Cholinergic Antagonists Cholinergic Muscarinic Antagonists Cholinesterase Inhibitors |
Suppliers and Packaging for NDA: 216903
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREVDUO | glycopyrrolate; neostigmine methylsulfate | SOLUTION;INTRAVENOUS | 216903 | NDA | Endo USA | 42023-269 | 42023-269-05 | 5 SYRINGE, PLASTIC in 1 CARTON (42023-269-05) / 3 mL in 1 SYRINGE, PLASTIC (42023-269-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.6MG/3ML (0.2MG/ML);3MG/3ML (1MG/ML) | ||||
| Approval Date: | Feb 23, 2023 | TE: | RLD: | Yes | |||||
| Patent: | 10,456,354 | Patent Expiration: | Oct 25, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,110,054 | Patent Expiration: | Oct 25, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,938,217 | Patent Expiration: | Oct 25, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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