Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets
Drug Approval

Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets

Cetirizine is used for relief of symptoms of hay fever and other allergic conditions

  • By IPP Bureau | October 04, 2024

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the 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 Indoco, at their manufacturing facility located at L-14, Verna Industrial Area, Verna, Goa – 403722 in India.

Cetirizine is used for relief of symptoms of hay fever and other allergic conditions.

Commenting on the achievement, Aditi Panandikar, Managing Director said, “This approval is a testament to Indoco’s commitment to delivering high-quality and affordable healthcare solutions to global markets. We are proud to contribute to providing effective allergy relief medicines and remain focussed in expanding our portfolio in the OTC space."

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