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-seven 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: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Nov 19, 2004 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Nov 19, 2004 | TE: | AB | 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 | ⤷ Sign Up | ⤷ Sign Up |
Astellas | VESICARE | solifenacin succinate | TABLET;ORAL | 021518-002 | Nov 19, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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