Liva Pharmaceuticals, a wholly owned subsidiary of Cadila Healthcare has received the approval from the USFDA for its supplemental abbreviated new drug application (sANDA), Ranitidine Injection USP, 25 mg/mL, 2 mL Single dose vials and 6 mL Multi-dose vials. It will be manufactured at Liva Pharma's manufacturing facility at Vadodara and is the first product to be approved from this site for marketing in the US.
Ranitidine belongs to the class of medications called H2antagonists and is used to treat stomach and duodenal (intestinal) ulcers, and prevent them from recurring. It is also used to treat gastroesophageal reflux disease (GERD) and ZollingerEllison Syndrome. The injectable form ofranitidine is given for short-term treatment of these conditions when a patient is unable to take this medication orally.
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