| 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 |