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Last Updated: August 5, 2020

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Details for New Drug Application (NDA): 210281

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NDA 210281 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 210281
Tradename:SOLIFENACIN SUCCINATE
Applicant:Jiangxi Boya Seehot
Ingredient:solifenacin succinate
Patents:0
Pharmacology for NDA: 210281
Medical Subject Heading (MeSH) Categories for 210281
Suppliers and Packaging for NDA: 210281
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210281 ANDA AustarPharma LLC 35561-285 35561-285-10 30 TABLET, FILM COATED in 1 BOTTLE (35561-285-10)
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210281 ANDA AustarPharma LLC 35561-285 35561-285-11 90 TABLET, FILM COATED in 1 BOTTLE (35561-285-11)

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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