USFDA approves Sun Pharma's generic Xanax ANDA

Sun Pharma announced that USFDA has granted an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Xanax®, alprazolam tablets.

These generic alprazolam tablets, equivalent to Pfizer's Xanax® tablets, include four strengths: 0.25 mg, 0.5 mg, 1 mg and 2 mg. Annual sale in US for these strengths of branded and generic alprazolam tablets is estimated at $145 million.

Alprazolam tablets are indicated for the management of anxiety disorder or the short-term relief of symptoms of anxiety. It is also indicated for the treatment of panic disorder, with or without agoraphobia.


 Sun Pharmaceutical Industries Ltd.


  1. paul carlson paul carlson United States says:

    Being a new product marketed by 'SUN PHARMA" and approved by the FDA; Plaese provide data on location of Pharmaceutical plant;any violations of strict 'sterile environment.
    I have tested your approved 2m.g. generic xanax. I was prescribed sun pharma,please inform me that sun pharma is manufactured in the U.S.A.If not the word will spread, sun pharma is weak and patients suffer to save afew bucks. The public knows about counterfiet medicine from China, India And north Korea etc. management make adjustments. Do the right thing.


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