Related by context. Frequent words. (Click for all words.) 68 Paragraph IV 60 Hatch Waxman Act 58 pediatric exclusivity 58 ANDAs 56 Hatch Waxman 55 Citizen Petition 53 Paragraph IV certification 53 Intellipharmaceutics 52 END FOOTNOTE 52 CFR § #.# [007] 52 ANDA 51 Permanent Injunction 51 CFR § #.# [005] 51 Omnitrope 51 Complete Response 51 Rev. Proc 51 Icatibant 51 INDs 51 Patent Litigation 51 Compl 50 FIRAZYR 50 Marketing Authorization 50 BLA submission 49 biogeneric 49 Annual Filings 49 '# patents 49 USC § #e 49 PDUFA 49 Act PDUFA 49 USCA § 49 GL c 49 Marketing Authorization Application 49 Mutual Recognition Procedure 49 Extended Release 48 Onsolis 48 Act PDUFA date 48 BAPCPA 48 Shelf Registration Statement 48 MNTX 48 Cladribine 48 Barr Laboratories Inc. 48 Certiorari 48 Biologics License Application BLA 48 Synthon 48 Orphan Drug Status 47 Oxandrin 47 ADAAA 47 Option Grants 47 ANDA approvals 47 FASB Statement 47 '# Patent 47 Biologics License Application 47 methylnaltrexone 47 PhosLo 47 AEDPA 47 Investigational 47 Renvela 47 ADDERALL XR 47 Speedy Trial Act 46 Drug Application 46 dronabinol 46 Rhucin ® 46 LIALDA 46 Upsher Smith 46 Drug Candidate 46 Second Amended Complaint 46 Citalopram 46 Approvable Letter 46 SEC Rule #b 46 sBLA 46 summary judgment motions 46 Marketing Authorization Application MAA 46 Plavix patent 46 European Medicines Evaluation 46 Priority Review 46 orphan designation 46 Extended Release Tablets 46 NASDAQ Listing 46 Ceftobiprole 46 Kuvan 46 ONTAK 46 pancreatic enzyme 46 Wis. Stat 45 Omeprazole 45 QbD 45 Cubicin 45 Sensipar 45 Controlled Substances 45 CPLR 45 Consent Agreement 45 USC § 45 FIFRA 45 Notice #-# [001] 45 NDAs 45 Duramed Pharmaceuticals Inc. 45 PRISTIQ 45 Loramyc ® 45 prGCD 45 § #-# [001] 45 Positive Opinion 45 Stalevo