Related by context. Frequent words. (Click for all words.) 70 ANDAs 67 Drug Application 66 Paragraph IV 64 Generic Version 62 ANDA 61 DMFs 60 Act PDUFA date 60 Panzem R 60 Abbreviated New 60 FDA Accepts 59 #mg #mg [002] 59 ANDA approvals 58 Extended Release Tablets 58 Par Pharmaceuticals 58 Drug Candidate 58 application sNDA 58 Mylan Pharmaceuticals Inc. 58 EPIX Pharmaceuticals 58 Marketing Authorization Application 57 Ondansetron 57 Pivotal Phase III 57 Application BLA 57 INDs 57 Hatch Waxman Act 57 Biologics License Application 57 Vfend 57 Drug Application ANDA 57 Oracea 57 TRANSDUR Sufentanil 57 USFDA approval 57 pediatric exclusivity 56 MNTX 56 oxybutynin 56 exclusivity periods 56 Andrx Corporation 56 Barr Laboratories Inc. 56 Visudyne R 56 PLAVIX R 56 AMRIX 56 Biologics License Application BLA 56 Patent Covering 56 Icatibant 56 Intellipharmaceutics 56 Hydrochloride 56 Patient Enrollment 56 Synthon 55 Teva Pharma 55 biogeneric 55 Biosimilar 55 silodosin 55 Lamivudine 55 Emend 55 Act PDUFA 55 Amneal 55 Octreotide 55 Pirfenidone 55 Opana ER 55 Eligard R 55 Atorvastatin 55 ISTA Pharmaceuticals 55 Onsolis 54 Complete Response 54 BLA submission 54 Vitaros 54 Pravastatin 54 ATryn ® 54 Akorn Inc. 54 New Chemical Entities 54 filgrastim 54 VALSTAR 54 FDA Orphan Drug 54 Orphan Drug Status 54 Extended Release 54 Actimmune R 54 Monoclonal Antibody 54 ecallantide 54 FIRAZYR 54 Roxane Laboratories Inc. 54 Orphan Drug Designation 54 Fortical 54 Omeprazole 54 supplemental Biologics License Application 54 sNDA 54 Marketing Authorization Application MAA 54 Opana R 54 Topiramate 54 Paragraph IV certification 54 Orphan Drug designation 54 Ixempra 54 Zelrix 54 intravenous formulations 53 Pennsaid R 53 Marketing Authorization 53 Phase III Clinical Trial 53 Junovan 53 Treximet 53 Exelbine 53 ponatinib 53 BioDelivery Sciences 53 Glenmark Generics 53 Avanafil