Related by context. Frequent words. (Click for all words.) 56 Abbreviated New 56 Drug Application 54 Biologics License Application BLA 52 Marketing Authorization Application MAA 52 Complete Response 52 Paragraph IV certification 52 Citizen Petition 52 ANDA 51 Marketing Authorization Application 51 ANDAs 50 NASDAQ Listing 50 Biologics License Application 50 BioDelivery Sciences 50 Pivotal Phase III 49 Marketing Authorization 49 Act PDUFA date 49 Investigational Device Exemption 48 IMPAX Laboratories Inc. 47 Orphan Drug Designation 47 Drug Application ANDA 47 sNDA 46 sBLA 46 Drug Administration USFDA 46 Preliminary Injunction 45 Barr Laboratories Inc. 45 PDUFA date 45 Priority Review 45 Impax Laboratories Inc. 45 USFDA 45 Investigational 44 Oscient 44 Factive 44 Final Approval 44 New Drug Application 44 alogliptin 43 INDs 43 Complete Response letter 43 Repros Therapeutics Inc. 43 Approvable Letter 43 NDA submission 43 orphan designation 43 Rehearing 43 FDA Approval 43 Hatch Waxman Act 42 Onsolis 42 Drug Administration FDA 42 Patent Application 42 filed 42 Natco Pharma 42 Omnitrope 42 LIALDA 42 Patent Litigation 41 pediatric exclusivity 41 Annual Filings 41 FDA 41 SFDA approval 41 Oral Solution 41 OTCQX RHHBY 41 interlocutory 41 Extended Release Tablets 41 Exalgo 41 Intellipharmaceutics 41 END FOOTNOTE 41 Special Leave Petition 40 Loramyc ® 40 ONSOLIS 40 Doc. # 40 Approval Process 40 rehearing en banc 40 Dkt 40 Compl 40 Rhucin 40 nunc pro tunc 40 CHMP opinion 40 orphan medicinal product 40 Orphan Drug designation 40 BioAlliance 40 Upsher Smith 40 Abstral 39 DCGI 39 CUBICIN 39 Oracea 39 Oral Suspension 39 Santhera 39 Fast Track Designation 39 Strativa 39 Zydus Cadila 39 Suven Life Sciences 39 Horizant 39 Orphan Drug 39 bazedoxifene 39 Qualifying Therapeutic Discovery 39 Strides Arcolab 39 Glumetza 39 Doc. No. 39 Rescission 39 XM Radio Investor Relations 39 Swissmedic 39 Apricus Bio 39 Preliminary Approval 38 Zelrix