escitalopram escitslopram tablet

1 INDICATIONS AND USAGE Escitalopram tablets are indicated for the treatment of: major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older. generalized anxiety disorder (GAD) in adults. Additional pediatric use information is approved for AbbVie Inc.'s LEXAPRO (escitalopram) tablets. However, due to AbbVie Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. Escitalopram tablet is a selective serotonin reuptake inhibitor (SSRI) indicated for the: treatment of major depressive disorder (MDD) in adults and pediatric patients 12 years of age and older ( 1 ) treatment of generalized anxiety disorder (GAD) in adults ( 1 )

lupin pharmaceuticals, inc.

FDA Reported Adverse Reactions
`[1] off label use` `[2] drug ineffective` `[3] drug dose omission by device` `[4] pyrexia` `[5] diarrhoea` `[6] nausea` `[7] dyspnoea` `[8] fatigue` `[9] headache` `[10] pneumonia`

6 years ago

ROUND WHITE W23

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Tablets Each film coated round tablet contains escitalopram oxalate equivalent to the labeled amount of escitalopram as follows 5 mg Tablets: white to off-white, round, film coated tablets, debossed with "LU" on one side and "W21" on the other side Bottles of 100 NDC 68180-137-01 10 mg Tablets: white to off-white, round, film coated tablets, debossed with 'L' and 'U' either side of the scoreline on one side and 'W22' on the other side. Bottles of 100 NDC 68180-135-01 20 mg Tablets: white to off-white, round, film coated tablets, debossed with 'L' and 'U' either side of the scoreline on one side and 'W23' on the other side. Bottles of 100 NDC 68180-136-01 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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