fesoterodine fumarate 4 mg

1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release tablets are indicated for the treatment of: Overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) 1.1 Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. Pediatric use information is approved for Pfizer Inc.’s TOVIAZ ® (fesoterodine fumarate) extended-release tablets. However, due to Pfizer Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

amneal pharmaceuticals llc

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] off label use` `[3] gynaecomastia` `[4] dyspnoea` `[5] fatigue` `[6] nausea` `[7] diarrhoea` `[8] headache` `[9] pain` `[10] weight increased`

2 years ago

OVAL BLUE A69

16 HOW SUPPLIED/STORAGE AND HANDLING

FESOTERODINE FUMARATE extended-release tablets, 4 mg, are supplied as light blue colored, oval shaped, and film-coated; debossed with “A 69” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-369-03 Bottles of 90: NDC 65162-369-09

FESOTERODINE FUMARATE extended-release tablets, 8 mg , are supplied as blue colored, oval shaped, and film-coated; debossed with “A 70” on one side and plain on the other side. They are available as follows: Bottles of 30: NDC 65162-370-03 Bottles of 90: NDC 65162-370-09 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

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