Details for New Drug Application (NDA): 206817
✉ Email this page to a colleague
The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 206817
Tradename: | SOLIFENACIN SUCCINATE |
Applicant: | Aurobindo Pharma |
Ingredient: | solifenacin succinate |
Patents: | 0 |
Pharmacology for NDA: 206817
Mechanism of Action | Cholinergic Muscarinic Antagonists |
Medical Subject Heading (MeSH) Categories for 206817
Suppliers and Packaging for NDA: 206817
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 206817 | ANDA | Aurobindo Pharma Limited | 65862-878 | 65862-878-03 | 3 BLISTER PACK in 1 CARTON (65862-878-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-878-10) |
SOLIFENACIN SUCCINATE | solifenacin succinate | TABLET;ORAL | 206817 | ANDA | Aurobindo Pharma Limited | 65862-878 | 65862-878-30 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-878-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Dec 27, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Dec 27, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription