Roxane Labs ANDA suitability petitions
Three additional ANDA route requests approved by FDA; one denied. Approved as ANDA suitable: furosemide oral solution 40 mg/5 ml, furosemide intensol 80 mg/ml, and propranolol HCl 20 mg/5 ml. Denied was request for diazepam intensol 10 mg/ml because the proposed concentration "is not appropriate for providing reasonable initial doses" for the elderly "or other likely populations".
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