Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210582
Company: CELLTRION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription AB No No
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/20/2019 ORIG-1 Approval STANDARD

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SOLIFENACIN SUCCINATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 205483 AJANTA PHARMA LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 205575 ALEMBIC PHARMS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210224 ALKEM LABS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209719 AMNEAL PHARMS CO
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209818 BRECKENRIDGE PHARM
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210582 CELLTRION
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209839 CIPLA
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209239 GLENMARK PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210281 JIANGXI BOYA SEEHOT
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 210688 MSN LABS PVT LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 209333 QILU PHARM CO LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 211657 SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 091464 TEVA PHARMS USA
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription No AB 202551 WATSON LABS INC
VESICARE SOLIFENACIN SUCCINATE 5MG TABLET;ORAL Prescription Yes AB 021518 ASTELLAS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 205483 AJANTA PHARMA LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 205575 ALEMBIC PHARMS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210224 ALKEM LABS LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209719 AMNEAL PHARMS CO
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209818 BRECKENRIDGE PHARM
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210582 CELLTRION
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209839 CIPLA
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209239 GLENMARK PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210281 JIANGXI BOYA SEEHOT
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 210688 MSN LABS PVT LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 209333 QILU PHARM CO LTD
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 211657 SCIEGEN PHARMS INC
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 091464 TEVA PHARMS USA
SOLIFENACIN SUCCINATE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription No AB 202551 WATSON LABS INC
VESICARE SOLIFENACIN SUCCINATE 10MG TABLET;ORAL Prescription Yes AB 021518 ASTELLAS

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