venlafaxine hydrochloride
Drug Details
- Generic Name
- venlafaxine hydrochloride
- Brand Names
- venlafaxine hydrochloride, venlafaxine, Venlafaxine Hydrochloride
- Application Number
- ANDA090174
- Sponsor
- NuCare Pharmaceuticals,Inc.
- NDC Codes
- 47
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET, TABLET, EXTENDED RELEASE, POWDER
- Routes
- ORAL
- Active Ingredients
- VENLAFAXINE HYDROCHLORIDE
Indications and Usage
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, USP 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.