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Last Updated: January 28, 2020

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Details for New Drug Application (NDA): 205575

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NDA 205575 describes SOLIFENACIN SUCCINATE, which is a drug marketed by Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Celltrion, Cipla, Cspc Ouyi, Glenmark Pharms Inc, Jiangxi Boya Seehot, Msn Labs Pvt Ltd, Qilu, Sciegen Pharms Inc, Strides Pharma, Teva Pharms Usa, Unichem Labs Ltd, and Watson Labs Inc, and is included in seventeen NDAs. It is available from twenty 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-three suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 205575
Applicant:Alembic Pharms Ltd
Ingredient:solifenacin succinate
Pharmacology for NDA: 205575
Medical Subject Heading (MeSH) Categories for 205575
Suppliers and Packaging for NDA: 205575
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205575 ANDA Alembic Pharmaceuticals Limited 46708-192 46708-192-08 80 TABLET, COATED in 1 CARTON (46708-192-08)
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205575 ANDA Alembic Pharmaceuticals Limited 46708-192 46708-192-30 30 TABLET, COATED in 1 BOTTLE (46708-192-30)

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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