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Last Updated: August 15, 2020

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Details for New Drug Application (NDA): 210582

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NDA 210582 describes SOLIFENACIN SUCCINATE, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Celltrion, Cipla, Glenmark Pharms Inc, Graviti Pharms, Jiangxi Boya Seehot, MSN, Qilu, Sciegen Pharms Inc, Strides Pharma, Sunshine Lake, Teva Pharms Usa, Unichem Labs Ltd, and Watson Labs Inc, and is included in eighteen NDAs. It is available from twenty-one suppliers. Additional details are available on the SOLIFENACIN SUCCINATE profile page.

The generic ingredient in SOLIFENACIN SUCCINATE is solifenacin succinate. There are thirty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 210582
Tradename:SOLIFENACIN SUCCINATE
Applicant:Celltrion
Ingredient:solifenacin succinate
Patents:0
Medical Subject Heading (MeSH) Categories for 210582

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 20, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 20, 2019TE:ABRLD:No

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