NDA TM Applicant Actives Form;Route
013217 SKELAXIN KING PHARMS METAXALONE TABLET;ORAL
018705 NITROLINGUAL POHL BOSKAMP NITROGLYCERIN AEROSOL;SUBLINGUAL
019386 BREVIBLOC BAXTER HLTHCARE ESMOLOL HYDROCHLORIDE INJECTABLE;INJECTION
019430 EPIPEN E Z PEN MYLAN SPECIALITY LP EPINEPHRINE INJECTABLE;INTRAMUSCULAR
019430 EPI E Z PEN JR MYLAN SPECIALITY LP EPINEPHRINE INJECTABLE;INTRAMUSCULAR
019627 DIPRIVAN FRESENIUS KABI USA PROPOFOL INJECTABLE;INJECTION
019734 CARDENE CHIESI USA INC NICARDIPINE HYDROCHLORIDE INJECTABLE;INJECTION
020280 GENOTROPIN PRESERVATIVE FREE PHARMACIA AND UPJOHN SOMATROPIN RECOMBINANT INJECTABLE;INJECTION
020372 MYOVIEW GE HEALTHCARE TECHNETIUM TC-99M TETROFOSMIN KIT INJECTABLE;INJECTION
020378 GONAL-F EMD SERONO FOLLITROPIN ALFA/BETA INJECTABLE;SUBCUTANEOUS
020381 NIASPAN ABBVIE NIACIN TABLET, EXTENDED RELEASE;ORAL
020381 NIASPAN TITRATION STARTER PACK ABBVIE NIACIN TABLET, EXTENDED RELEASE;ORAL
020533 NAROPIN FRESENIUS KABI USA ROPIVACAINE HYDROCHLORIDE SOLUTION;INJECTION
020563 HUMALOG PEN LILLY INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION
020622 COPAXONE TEVA PHARMS USA GLATIRAMER ACETATE FOR SOLUTION;SUBCUTANEOUS
020667 MIRAPEX BOEHRINGER INGELHEIM PRAMIPEXOLE DIHYDROCHLORIDE TABLET;ORAL
020908 VAGIFEM NOVO NORDISK INC ESTRADIOL TABLET;VAGINAL
021017 HUMALOG MIX 75/25 PEN LILLY INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION
021018 HUMALOG MIX 50/50 PEN LILLY INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT INJECTABLE;INJECTION
021148 NORDITROPIN NOVO NORDISK INC SOMATROPIN RECOMBINANT INJECTABLE;INJECTION
021149 OVIDREL EMD SERONO CHORIOGONADOTROPIN ALFA INJECTABLE;INJECTION
021160 PHOSLO FRESENIUS MEDCL CALCIUM ACETATE CAPSULE;ORAL
021172 NOVOLOG MIX 70/30 PENFILL NOVO NORDISK INC INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT INJECTABLE;SUBCUTANEOUS
021223 ZOMETA NOVARTIS ZOLEDRONIC ACID INJECTABLE;IV (INFUSION)
021252 CANASA ALLERGAN SALES LLC MESALAMINE SUPPOSITORY;RECTAL
021284 RITALIN LA NOVARTIS METHYLPHENIDATE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL
021572 CUBICIN CUBIST PHARMS LLC DAPTOMYCIN POWDER;IV (INFUSION)
021695 ANTARA (MICRONIZED) LUPIN ATLANTIS FENOFIBRATE CAPSULE;ORAL
201922 XIMINO SUN PHARM INDS LTD MINOCYCLINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL
204824 OTREXUP PFS ANTARES PHARMA INC METHOTREXATE SOLUTION;SUBCUTANEOUS
206317 TRIFERIC ROCKWELL MEDICAL INC FERRIC PYROPHOSPHATE CITRATE SOLUTION;INTRAVENOUS