The product will be commercialised from Unichem's Goa plant on receipt of final approval.
Unichem Laboratories on May 7 said it has received tentative approval from the US health regulator for its generic copy of allergic rhinitis Johnson & Johnson Consumer Inc's Zyrtec-D 12 Hour used for treating allergic rhinitis.
The tentative nod by the US Food and Drug Administration (USFDA) is for the company's Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride extended-release tablets, 5 mg/120 mg, Unichem Laboratories said in a regulatory filing.
The over the counter product is also indicated as a nasal decongestant.
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