Related by context. Frequent words. (Click for all words.) 63 ANDA 63 Abbreviated New 61 Drug Application ANDA 61 Drug Application 59 ANDAs 59 pediatric exclusivity 57 Complete Response 56 Glumetza 56 Oral Solution 56 Citizen Petition 56 Oral Suspension 55 Barr Laboratories Inc. 55 Keflex 54 '# patent 54 bioequivalent 54 Citalopram 54 Act PDUFA date 53 Hatch Waxman Act 53 approvable letter 53 Omeprazole 52 Biologics License Application BLA 52 Ondansetron 52 Zegerid 52 Duramed Pharmaceuticals Inc. 52 '# Patent 52 Lidoderm 52 Teva Pharmaceuticals USA 52 Olanzapine 52 Approvable Letter 52 Extended Release Tablets 52 Pulmicort 51 Oxandrin 51 Oracea 51 Gabapentin 51 Oscient 51 Effexor XR 51 USFDA 51 Aciphex 51 #mg #mg [003] 51 Biologics License Application 51 Protopic 50 Opana ER 50 Marketing Authorization Application MAA 50 mg dosage 50 Marketing Authorization 50 '# patents 50 Factive 50 Mylan Pharmaceuticals Inc. 50 Par Pharmaceutical 50 ADDERALL XR 50 Horizant 50 Complete Response letter 50 Onsolis 50 BioDelivery Sciences 50 Lamivudine 49 tradename 49 Icatibant 49 sBLA 49 ALZA 49 Intellipharmaceutics 49 LIALDA 49 PhosLo 49 Famvir 49 Drug Administration USFDA 49 Patent Application 49 Complete Response Letter 49 Reloxin 49 NASDAQ Listing 49 Full Prescribing Information 49 GRAS status 49 AndroGel 49 sodium phosphate dibasic anhydrous 49 CHMP opinion 48 Duramed 48 Stalevo 48 Staff Determination Letter 48 Caduet 48 Bupropion 48 Indiplon 48 Bioniche Pharma 48 Hatch Waxman 48 MDCO 48 Gestiva 48 ZEGERID 48 VIMOVO 48 Exalgo 48 Critical Therapeutics 48 alogliptin 48 ISTA Pharmaceuticals 48 Stelara 48 NYSE PRX 48 SCOLR 47 Acurox 47 Initial Determination 47 Amended Complaint 47 BLA submission 47 FDA Approval 47 New Drug Application 47 Hylenex 47 Sun Pharmaceutical Industries 47 EPIX Pharmaceuticals