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JB Chemicals gets ANDA approval from US FDA for Loratadine Tablets

expresspharmaJanuary 12, 2021

Tag: JB Chemicals , ANDA , FDA , Loratadine Tablets , Allergic rhinitis

The US FDA has approved JB Chemicals & Pharmaceuticals’ Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg.

They are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for over-the-counter (OTC) use.

This product is generic version of Clartin tablet in the same strength of Bayer Healthcare. The company expects to commercialise this product in Q1 of FY 2021-22.

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