Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091464

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NDA 091464 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, Jiangxi Boya Seehot, Msn Labs Pvt Ltd, Qilu Pharm Co Ltd, Sciegen Pharms Inc, Strides Pharma, Teva Pharms Usa, Unichem Labs Ltd, and Watson Labs Inc, and is included in sixteen 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-four suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 091464
Tradename:SOLIFENACIN SUCCINATE
Applicant:Teva Pharms Usa
Ingredient:solifenacin succinate
Patents:0
Pharmacology for NDA: 091464
Medical Subject Heading (MeSH) Categories for 091464
Suppliers and Packaging for NDA: 091464
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 091464 ANDA Teva Pharmaceuticals USA, Inc. 0093-5263 0093-5263-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-5263-56)
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 091464 ANDA Teva Pharmaceuticals USA, Inc. 0093-5263 0093-5263-98 90 TABLET, FILM COATED in 1 BOTTLE (0093-5263-98)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 2, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Apr 2, 2014TE:ABRLD:No

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