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ALLEGAN, Mich. — Perrigo on Monday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter ranitidine 150 (regular and cool mint), a generic version of Zantac 150.
Zantac 150 has annual sales of approximately $110 million, as measured by SymphonyIRI Group, Perrigo reported.
"This approval is the first from our Allegan, Mich., facility since the company returned to acceptable regulatory status. It is another example of Perrigo's commitment to bring new products to market,” Perrigo chairman and CEO Joseph Papa said.