Related by context. Frequent words. (Click for all words.) 62 ANDAs 60 Paragraph IV 58 ANDA approvals 57 DMFs 55 Act PDUFA date 54 INDs 54 Marketing Authorization Application 53 Abbreviated New 53 risks anduncertainties 53 Mutual Recognition Procedure 52 ANDA 52 supplemental Biologics License Application 52 FDA Accepts 52 exclusivity periods 52 USFDA 51 Generic Version 51 Exelbine 51 Drug Application 51 Biologics License Application BLA 51 SFDA approval 51 biogeneric 51 Rhucin ® 51 Lupin Ltd 51 Marketing Authorization Application MAA 50 obj obj = 50 Drug Administration USFDA 50 NDAs 50 MONOVISC 50 Biologics License Application 50 prGCD 50 Cipla Ltd 50 USFDA approval 50 Intellipharmaceutics 49 Visudyne R 49 ISTA Pharmaceuticals 49 application sNDA 49 Eligard R 49 Loramyc ® 49 pediatric exclusivity 49 EPIX Pharmaceuticals 49 DCGI 49 India DCGI 49 Citizen Petition 49 generic injectable 49 Onsolis 49 Complete Response letter 48 Mitigation Strategy REMS 48 Fortical 48 sBLA 48 Priority Review 48 Plenaxis R 48 Omnitrope 48 Orphan Drug Status 48 Somaxon Pharmaceuticals 48 ONSOLIS 48 GEM #S 48 Oxandrin 48 Par Pharmaceuticals 47 Shire ADHD 47 BEMA Fentanyl 47 Boxed Warning 47 Opana ER 47 Amneal 47 Oracea 47 Icatibant 47 Captisol 47 Orphan Drug status 47 Complete Response 47 Glenmark Generics 47 Shasun Chemicals 47 dalbavancin 47 Active Pharmaceutical Ingredients 47 patent expiry 47 Medicinal Products EMEA 47 Poly ICR 47 ATryn ® 47 BLA submission 47 Patent Litigation 46 Strativa 46 Orphan Drug designation 46 PLIVA dd 46 Abstral 46 Drug Application ANDA 46 APF# 46 Natco Pharma 46 Interpharm 46 #mg #mg [003] 46 Pantoprazole 46 approvals 46 Barr Laboratories Inc. 46 Marketing Authorization 46 biosimilar 46 Phase IIa clinical trials 46 orphan designation 46 CE Marked 46 SCHWARZ PHARMA 46 Zelrix 46 JZP 6 46 Cladribine Tablets 46 Omeprazole 46 Exalgo