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FDA Drug information

Solifenacin

Read time: 1 mins
Marketing start date: 23 Dec 2024

Summary of product characteristics


Effective Time

20221017

Version

2

Spl Product Data Elements

Solifenacin Solifenacin SOLIFENACIN SUCCINATE SOLIFENACIN FERRIC OXIDE YELLOW HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED STARCH, CORN TALC TITANIUM DIOXIDE LIGHT YELLOW BICONVEX 987 Solifenacin Solifenacin SOLIFENACIN SUCCINATE SOLIFENACIN STARCH, CORN HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE TALC FERRIC OXIDE RED LIGHT PINK BICONVEX 988

Application Number

ANDA207721

Brand Name

Solifenacin

Generic Name

Solifenacin

Product Ndc

70771-1605

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1604-3 Solifenacin succinate tablets, 5 mg Rx only 30 tablets NDC 70771-1605-3 Solifenacin succinate tablets, 10 mg Rx only 30 tablets 5 mg 10 mg

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