From USFDA
Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Loperamide Hydrochloride Tablet, 2 mg. This product is expected to be launched in Q4 FY2015-16.The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Imodium A-D Tablets, 2 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Imodium A-D Tablets, 2 mg, of Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division.
This is the 53rd ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 223 ANDA approvals (195 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.
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