venlafaxine hydrochloride capsule extended release 37.5 mg
1 INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: • major depressive disorder (MDD) • Generalized Anxiety Disorder (GAD) • Social Anxiety Disorder (SAD) • Panic Disorder (PD) 1.1 major depressive disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials. 1.4 Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.
camber pharmaceuticals, inc.
CAPSULE GREY V 9
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16 HOW SUPPLIED/STORAGE AND HANDLING
VENLAFAXINE HYDROCHLORIDE extended-release capsules USP are available as follows:
VENLAFAXINE HYDROCHLORIDE extended-release capsules USP, 37.5 mg are white to off white colored, round to oval shaped pellets filled in size '3' hard Gelatin capsules with grey opaque cap imprinted with 'V' in black color, white opaque body imprinted with '9' in black color. Bottle of 30 capsules NDC 31722-002-30 Bottle of 90 capsules NDC 31722-002-90 Bottle of 500 capsules NDC 31722-002-05 Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-002-01
VENLAFAXINE HYDROCHLORIDE extended-release capsules USP, 75 mg are white to off white colored, round to oval shaped pellets filled in size '1' hard Gelatin capsules with peach opaque cap imprinted with 'V' in black color, white opaque body imprinted with '10' in black color. Bottle of 30 capsules NDC 31722-003-30 Bottle of 90 capsules NDC 31722-003-90 Bottle of 500 capsules NDC 31722-003-05 Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-003-01
VENLAFAXINE HYDROCHLORIDE extended-release capsules USP, 150 mg are white to off white colored, round to oval shaped pellets filled in size '0' hard Gelatin capsules with orange opaque cap imprinted with 'V' in black color, white opaque body imprinted with '11' in black color. Bottle of 30 capsules NDC 31722-004-30 Bottle of 90 capsules NDC 31722-004-90 Bottle of 500 capsules NDC 31722-004-05 Carton of 100 (10 x 10) unit-dose capsules (Alu-Blister pack) NDC 31722-004-01 Store at controlled room temperature, 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]
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