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Indoco Remedies gets USFDA’s approval for Cetirizine Hydrochloride Tablets

04 Oct 2024 Evaluate

Indoco Remedies has received final approval from the US Food and Drug Administration (USFDA) for Abbreviated New Drug Application (ANDA) for Cetirizine Hydrochloride Tablets USP, 10 mg (OTC), a generic equivalent of the Reference Listed Drug, Zyrtec Allergy Tablets, 10 mg of Johnson & Johnson Consumer Inc.

Cetirizine Hydrochloride Tablets USP, 10 mg will be manufactured by the company, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa. Cetirizine is used for relief of symptoms of hay fever and other allergic conditions.

Indoco Remedies is engaged in the manufacturing and marketing of formulations (finished dosage forms) and active pharmaceutical ingredients (APIs) in India.


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