Related by context. Frequent words. (Click for all words.) 70 Paragraph IV certification 67 ANDA 66 Drug Application ANDA 66 ANDAs 66 Drug Application 64 Paragraph IV 62 Abbreviated New 60 Biologics License Application 59 application sNDA 59 Biologics License Application BLA 59 FDA approvable letter 58 FDA Accepts 58 Opana ER 58 USFDA approval 57 Marketing Authorization Application MAA 57 Generic Version 57 Par Pharmaceuticals 56 Act PDUFA date 56 Extended Release Tablets 56 sBLA 56 supplemental Biologics License Application 55 OFIRMEV 55 Solzira 55 Oracea 55 alogliptin 55 Acetavance 55 Omigard 55 Company Nasdaq PRGO 55 Complete Response 55 silodosin 55 Omeprazole 55 ZALBIN 55 Marketing Authorization Application 55 Glumetza 55 Zegerid 55 New Drug Application 55 Femcon Fe 55 Pennsaid R 54 Dyloject 54 Extended Release 54 Intellipharmaceutics 54 dalbavancin 54 Clevudine 54 sNDA 54 Synthon 54 Alvesco 54 BENLYSTA 54 Ondansetron 54 Hatch Waxman Act 54 Keflex 54 Apricus Bio 54 pediatric exclusivity 54 #mg tablets [001] 54 Pravastatin 54 Exalgo 54 Market Approval PMA 54 Advicor 53 Indiplon 53 Effexor XR 53 Exelbine 53 MONOVISC 53 Glenmark Generics 53 therapeutically equivalent 53 Pennsaid 53 Emend 53 NUVIGIL 53 Icatibant 53 Upsher Smith 53 Caduet 53 Barr Laboratories Inc. 53 mg capsules 53 Paladin Labs 53 Vitaros 52 tablet formulation 52 Focalin XR 52 PLAVIX R 52 Onsolis 52 NEBIDO 52 Hydrochloride 52 Oral Solution 52 Nexavar ® 52 Trexima 52 Panzem R 52 Zanaflex Capsules 52 Complete Response letter 52 bioequivalent 52 Sancuso 52 NYSE MYL 52 Abstral 52 Cubicin 52 Oral Suspension 52 Oscient 52 Renvela 52 DMFs 52 intravenous formulation 52 IPXL 52 Factive 52 Somaxon Pharmaceuticals 52 Neurodex 52 Nasdaq VRTX 52 Teva Pharmaceuticals USA