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Federal Register notice: FDA determines that Corden Pharma Latinas Cefzil (cefprozil) tablets, 250mg and 500mg mg, and Cefzil for ...[ Price : $8.95]
FDA approves a Teva 505(b)(2) NDA for Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid...[ Price : $8.95]
FDA issues GlaxoSmithKline a complete response letter for its supplemental BLA for mepolizumab as an add-on treatment to inhaled c...[ Price : $8.95]
FDA clears a Masimo 510(k) for the RAS-45, an acoustic respiration sensor for its Rainbow Acoustic Monitor (RAM) for infant and ne...[ Price : $8.95]
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs National Mammography Quality Assurance Advi...[ Price : $8.95]
FDA extends by three months the review of a Genentech supplemental BLA for Tecentriq (atezolizumab) for use in combination with Av...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Policy Regarding Quantitative Labeling of Dietary Supplemen...[ Price : $8.95]
FDA approves labeling changes for three ViiV HIV drugs containing dolutegravir to address risk of neural tube defects.