Unichem Labs gets USFDA nod for Amitriptyline HCl Tablets
Mumbai: Drugmajor, Unichem Laboratories Limited, has recently announced that the company has received ANDA approval for its Amitriptyline HCl Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg from the United States Food and Drug Administration (USFDA).
The product is a generic version of ELAVIL (Amitriptyline Hydrochloride) 10 mg, 25 mg, 50 mg, 75 mg, 100 mg and 150 mg of AstraZeneca Pharmaceuticals LP.
Amitriptyline HCl Tablets are indicated for the relief of symptoms of depression.
The product will be commercialized from Unichem's Goa Plant.