escitalopram as escitalopram oxalate 10 MG Oral Tablet

1 INDICATIONS AND USAGE Escitalopram 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 ) 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.

Torrent Pharmaceuticals Limited

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

11 years ago

ROUND WHITE 11 36 10

11 years ago

11 36 10 ROUND WHITE

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Escitalopram tablets, USP 5 mg are white to off-white, round, biconvex, film coated tablets debossed with '135' on one side and '5' on other side. Bottles of 30 NDC 13668-135-30 Bottles of 100 NDC 13668-135-01 Bottles of 500 NDC 13668-135-05 Bottles of 1000 NDC 13668-135-10 Bottles of 4000 NDC 13668-135-40 Escitalopram tablets, USP 10 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '36' on one side, and '10' on other side. Bottles of 30 NDC 13668-136-30 Bottles of 100 NDC 13668-136-01 Bottles of 500 NDC 13668-136-05 Bottles of 1000 NDC 13668-136-10 Bottles of 3000 NDC 13668-136-43 Escitalopram tablets, USP 20 mg are white to off-white, round, biconvex, film coated tablets debossed with break line on one side, separating '11' and '37' on one side, and '20' on other side. Bottles of 30 NDC 13668-137-30 Bottles of 100 NDC 13668-137-01 Bottles of 500 NDC 13668-137-05 Bottles of 1000 NDC 13668-137-10 Bottles of 2000 NDC 13668-137-20 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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