JB Chemicals gets ANDA approval from US FDA for Loratadine Tablets
The tablets are indicated for the treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy for OTC use
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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