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news.Hi-Tech Pharmacal has received US Food & Drug Administration's (FDA) final approval for its abbreviated new drug application (ANDA) for Ranitidine syrup 15mg/ml.
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Hi-Tech Pharmacal claims Ranitidine syrup is the generic version of GlaxoSmithKline’s Zantac syrup.
Ranitidine syrup is indicated for the treatment of duodenal ulcers.
Hi-Tech Pharmacal is a specialty pharmaceutical company that develops, manufactures and markets generic and branded prescription and OTC products.
The company has 13 products awaiting approval at the FDA and 20 products, including sterile ophthalmic products, oral solutions and suspensions and nasal sprays, under active development.