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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 210688


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NDA 210688 describes SOLIFENACIN SUCCINATE, which is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma, Austarpharma, Breckenridge, Chartwell Rx, Cipla, Glenmark Pharms Inc, Lannett Co Inc, MSN, Qilu, Rising, Sciegen Pharms Inc, Strides Pharma, Sunshine, Teva Pharms Usa, Unichem, Watson Labs Inc, and Zydus Pharms, and is included in twenty-three NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the solifenacin succinate profile page.
Summary for 210688
Tradename:SOLIFENACIN SUCCINATE
Applicant:Msn
Ingredient:solifenacin succinate
Patents:0
Pharmacology for NDA: 210688
Medical Subject Heading (MeSH) Categories for 210688
Suppliers and Packaging for NDA: 210688
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210688 ANDA MSN LABORATORIES PRIVATE LIMITED 69539-050 69539-050-81 30 TABLET in 1 BOTTLE (69539-050-81)
SOLIFENACIN SUCCINATE solifenacin succinate TABLET;ORAL 210688 ANDA MSN LABORATORIES PRIVATE LIMITED 69539-050 69539-050-82 90 TABLET in 1 BOTTLE (69539-050-82)

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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