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Unichem Laboratories gets FDA approval for Amitriptyline HCl Tablets generic

bySrinath
May 21, 2021
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Unichem Laboratories, an Indian specialty pharma company, said that it has secured abbreviated new drug application (ANDA) approval for its Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the US Food and Drug Administration (FDA).

Amitriptyline HCl Tablets are a generic version of ELAVIL (Amitriptyline Hydrochloride) 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg owned by AstraZeneca Pharmaceuticals.

The tablets have FDA approval for the treatment of symptoms of depression.

Unichem Laboratories said that its Amitriptyline HCl Tablets will be manufactured at its plant in Goa.

Unichem Laboratories gets FDA approval for Amitriptyline HCl Tablets USP
Unichem Laboratories gets FDA approval for Amitriptyline HCl Tablets USP. Photo courtesy of The U.S. Food and Drug Administration/Wikipedia.org.

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bySrinath