Complete List of Currently Approved NDA and ANDA Application Submissions

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Complete List of Currently Approved Premarket Approvals (PMAs)

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February 24, 2011 Approval Letter

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Irinotecan Hydrochloride Injection: Recall

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FDA Drug Safety Communication: Special storage and handling requirements must be followed for Pradaxa (dabigatran etexilate mesylate) capsules

  Safety AnnouncementAdditional Information for PatientsAdditional Information for Healthcare ProfessionalsData Summary   Safety Announcement [03-29-2011] The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa (dabigatran etexilate mesylate) capsules. Due to the potential for product breakdown from moisture and loss of potency, Pradaxa capsules should only…

Pediatric Exclusivity Granted

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Current Drug Shortages

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