Details for New Drug Application (NDA): 209529
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NDA 209529 describes VESICARE LS, which is a drug marketed by Astellas and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the VESICARE LS profile page.
The generic ingredient in VESICARE LS is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
The generic ingredient in VESICARE LS is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 209529
| Tradename: | VESICARE LS |
| Applicant: | Astellas |
| Ingredient: | solifenacin succinate |
| Patents: | 1 |
Pharmacology for NDA: 209529
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 209529
Suppliers and Packaging for NDA: 209529
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VESICARE LS | solifenacin succinate | SUSPENSION;ORAL | 209529 | NDA | Astellas Pharma US, Inc. | 51248-250 | 51248-250-99 | 1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | 1MG/ML | ||||
| Approval Date: | May 26, 2020 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 18, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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