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USFDA approves Sun Pharma's generic Venlafaxine Hydrochloride Extended Release tablets ANDA
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- Publication:2010/8/20
Sun Pharma announced that USFDA has granted an approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Venlafaxine Hydrochloride Extended Release tablets.
These generic extended release Venlafaxine tablets are therapeutically equivalent to Osmotica's Venlafaxine Hydrochloride Extended Release tablets and include three strengths: 37.5 mg (base), 75 mg (base), 150 mg (base).
Venlafaxine Hydrochloride extended release tablets are indicated for the management of major depressive disorder.
The product will reach the market shortly.
SOURCE Sun Pharmaceutical Industries Ltd.