Bupropion Hydrochloride 100 MG Oral Tablet

1 INDICATIONS AND USAGE Bupropion hydrochloride tablets USP are indicated for the treatment of major depressive disorder (MDD), as defined by the Diagnostic and Statistical Manual (DSM). The efficacy of bupropion hydrochloride tablets USP in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with MDD [see Clinical Studies (14)] . Bupropion hydrochloride tablets USP are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) (1)

Alembic Pharmaceuticals Limited

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

5 years ago

ROUND YELLOW L 296

5 years ago

L 296 ROUND YELLOW

16 HOW SUPPLIED/STORAGE AND HANDLING

BUPROPION HYDROCHLORIDE tablets USP, 75 mg are light orange colored, round, biconvex film coated tablets debossed with ‘L295’ on one side and plain on other side. Bottles of 100 NDC # 46708-118-31 Bottles of 1000 NDC # 46708-118-91

BUPROPION HYDROCHLORIDE tablets USP, 100 mg are light yellow colored, round, biconvex film coated tablets debossed with ‘L296’ on one side and plain on other side. Bottles of 100 NDC # 46708-127-31 Bottles of 500 NDC # 46708-127-71 Store at 15° to 25°C (59° to 77°F). Protect from light and moisture.

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alembic pharmaceuticals limited

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