Details for New Drug Application (NDA): 021518
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The generic ingredient in VESICARE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 021518
| Tradename: | VESICARE |
| Applicant: | Astellas |
| Ingredient: | solifenacin succinate |
| Patents: | 0 |
Pharmacology for NDA: 021518
| Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 021518
Suppliers and Packaging for NDA: 021518
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VESICARE | solifenacin succinate | TABLET;ORAL | 021518 | NDA | Astellas Pharma US, Inc. | 51248-150 | 51248-150-01 | 30 TABLET, FILM COATED in 1 BOTTLE (51248-150-01) |
| VESICARE | solifenacin succinate | TABLET;ORAL | 021518 | NDA | Astellas Pharma US, Inc. | 51248-151 | 51248-151-01 | 30 TABLET, FILM COATED in 1 BOTTLE (51248-151-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 19, 2004 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 19, 2004 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021518
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-001 | Nov 19, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-002 | Nov 19, 2004 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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