Related by context. Frequent words. (Click for all words.) 65 ANDAs 53 INDs 48 sBLA 48 BENLYSTA 47 ANDA 47 Biologics License Application 46 Oxandrin 45 pediatric exclusivity 45 Biologics License Application BLA 44 biogeneric 44 SFDA approval 44 PREOS 44 Annual Filings 43 Form #Q 43 Factive 43 Marketing Authorization Application 43 Oracea 43 OFIRMEV 43 Zelrix 42 patent expiry 42 Complete Response 42 sNDA 42 lubiprostone 41 Camptosar 41 Upsher Smith 41 FACTIVE 41 Stelara 41 Renvela 41 Zanaflex Capsules 41 Apricus Bio 41 Final Prospectus 41 Loramyc ® 41 Stalevo 41 SANCTURA XR 40 Oscient 40 mg dosage 40 Abbreviated New 40 PhosLo 40 Caduet 40 Intellipharmaceutics 40 KRYSTEXXA 40 ADDERALL XR 40 Act PDUFA date 40 Form #KSB 40 APF# 39 NDA submission 39 ecallantide 39 Opana ER 39 Icatibant 39 Hatch Waxman Act 39 Priority Review 39 Orphan Drug Designation 39 Orphan Drug designation 39 crofelemer 39 BYDUREON 39 REPLAGAL 39 Investigational 39 Dyloject 39 generic injectable 39 PDUFA date 39 ONSOLIS 39 Zydus Cadila 39 anti infective 39 asenapine 39 exclusivity periods 39 Genentech Roche 38 Lidoderm 38 Omeprazole 38 Keflex 38 Effexor XR 38 Glumetza 38 Lialda 38 Drug Application 38 Testim 38 Bayer Schering 38 CUBICIN 38 REMOXY 38 Increlex 38 NovaDel 38 accompanying Management Discussion 38 Approvable Letter 37 biosimilar 37 GLUMETZA 37 Exalgo 37 JANUVIA 37 Onsolis 37 BioDelivery Sciences 37 Paragraph IV certification 37 Treximet 37 Strativa 37 generic 37 Form# K 37 OLEPTRO TM 37 Victrelis 37 Guided Therapeutics 37 QSB 37 SCOLR 37 VYVANSE 37 Extended Release Tablets 37 Bioxel 37 cephalosporin