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Last Updated: September 23, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205483

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NDA 205483 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 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 205483
Applicant:Ajanta Pharma Ltd
Ingredient:solifenacin succinate
Pharmacology for NDA: 205483
Medical Subject Heading (MeSH) Categories for 205483
Suppliers and Packaging for NDA: 205483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205483 ANDA Ajanta Pharma Limited 27241-037 27241-037-03 30 TABLET, FILM COATED in 1 BOTTLE (27241-037-03)
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 205483 ANDA Ajanta Pharma Limited 27241-037 27241-037-09 90 TABLET, FILM COATED in 1 BOTTLE (27241-037-09)

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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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Johnson and Johnson

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