Bupropion Hydrochloride 100 MG Oral Tablet
1 INDICATIONS AND USAGE Bupropion hydrochloride tablets 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 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 are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD). ( 1 )
Apotex Corp
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16 HOW SUPPLIED/STORAGE AND HANDLING
BUPROPION HYDROCHLORIDE tablets, USP 75 mg are available for oral administration as orange, round, unscored, film coated tablets, imprinted "APO" on one side and "BU" over "75" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0158-3) Bottles of 90 (NDC 60505-0158-9) Bottles of 100 (NDC 60505-0158-1) Bottles of 500 (NDC 60505-0158-5) Bottles of 1,000 (NDC 60505-0158-7)
BUPROPION HYDROCHLORIDE tablets, USP 100 mg are available for oral administration as purple, round, unscored, film coated tablets, imprinted "APO" on one side and "BUP" over "100" on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0157-3) Bottles of 90 (NDC 60505-0157-9) Bottles of 100 (NDC 60505-0157-1) Bottles of 500 (NDC 60505-0157-5) Bottles of 1,000 (NDC 60505-0157-7) Store at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted from 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Store in a tight, light resistant container [see USP].
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