| NDA # |
DRUG NAME |
GENERIC NAME |
APPLICANT |
CLASS |
APPROVAL DATE |
DOSAGE FORM |
|
|
|
|
|
|
|
| 20-181 |
LIPOSYN III |
SOYBEAN OIL |
ABBOTT LABS |
3 S |
13-Jan-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-802 |
EXCEDRIN |
ACETAMINOPHEN/ASPIRIN/ CAFFEINE |
BRISTOL MYERS |
7 S |
14-Jan-98 |
TABLET |
|
|
|
|
|
|
|
| 20-697 |
TASMAR |
TOLCAPONE |
HOFFMAN LA-ROCHE |
1 S |
29-Jan-98 |
TABLET |
|
|
|
|
|
|
|
| 20-812 |
PEDIATRIC ADVIL |
IBUPROFEN |
WHITEHALL ROBINS |
3 S |
30-Jan-98 |
SUSPENSION |
|
|
|
|
|
|
|
| 50-731 |
DAUNORUBICIN HCL |
DAUNORUBICIN HYDROCHLORIDE |
BEDFORD LABS |
3 S |
30-Jan-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-962 |
EMLA |
LIDOCAINE/PRILOCAINE |
ASTRA PHARMS |
3 S |
4-Feb-98 |
DISC |
|
|
|
|
|
|
|
| 20-763 |
AMERGE |
NARATRIPTAN HYDROCHLORIDE |
GLAXO WELLCOME |
1 S |
10-Feb-98 |
TABLET |
|
|
|
|
|
|
|
| 20-805 |
CIPRO HC |
CIPROFLOXACIN HYDROCHLORIDE/ HYDROCORTISONE |
BAYER |
3 S |
10-Feb-98 |
SUSPENSION |
|
|
|
|
|
|
|
| 20-829 |
SINGULAIR |
MONTELUKAST SODIUM |
MERCK |
1 S |
20-Feb-98 |
TABLET |
|
|
|
|
|
|
|
| 20-830 |
SINGULAIR |
MONTELUKAST SODIUM |
MERCK |
3 S |
20-Feb-98 |
TABLET |
|
|
|
|
|
|
|
| 50-750 |
ZOSYN |
PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM |
LEDERLE |
3 S |
24-Feb-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-745 |
ZANTAC 75 |
RANITIDINE HYDROCHLORIDE |
GLAXO WELLCOME |
3 S |
26-Feb-98 |
TABLET |
|
|
|
|
|
|
|
| 20-906 |
ETOPOPHOS |
ETOPOSIDE PHOSPHATE |
BRISTOL MYERS SQUIBB |
3 S |
27-Feb-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-807 |
REFLUDAN |
LEPIRUDIN |
HOECHST MARION RSSL |
1 P |
6-Mar-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-818 |
DIOVAN HCT |
HYDROCHLOROTHIAZIDE/ VALSARTAN |
NOVARTIS PHARMS |
4 S |
6-Mar-98 |
TABLET |
|
|
|
|
|
|
|
| 20-583 |
LOTEMAX |
LOTEPREDNOL ETABONATE |
PHARMOS |
1 S |
9-Mar-98 |
SUSPENSION |
|
|
|
|
|
|
|
| 20-803 |
ALREX |
LOTEPREDNOL ETABONATE |
PHARMOS |
3 S |
9-Mar-98 |
SUSPENSION |
|
|
|
|
|
|
|
| 20-771 |
DETROL |
TOLTERODINE TARTRATE |
PHARMACIA & UPJOHN |
1 S |
25-Mar-98 |
TABLET |
|
|
|
|
|
|
|
| 20-835 |
ACTONEL |
RISEDRONATE SODIUM |
PROCTER & GAMBLE PHARM |
1 S |
27-Mar-98 |
TABLET |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| 20-895 |
VIAGRA |
SILDENAFIL CITRATE |
PFIZER |
1 P |
27-Mar-98 |
TABLET |
|
|
|
|
|
|
|
| 20-369 |
CILOXAN |
CIPROFLOXACIN HYDROCHLORIDE |
ALCON |
3 S |
30-Mar-98 |
OINTMENT |
|
|
|
|
|
|
|
| 20-827 |
MONISTAT 3 |
MICONAZOLE NITRATE |
ADVANCED CARE |
3 S |
30-Mar-98 |
CREAM |
|
|
|
|
|
|
|
| 20-816 |
AZOPT |
BRINZOLAMIDE |
ALCON |
1 S |
1-Apr-98 |
SUSPENSION |
|
|
|
|
|
|
|
| 20-869 |
COSOPT |
DORZOLAMIDE HYDROCHLORIDE/ TIMOLOL MALEATE |
MERCK RES |
4 S |
7-Apr-98 |
SOLUTION |
|
|
|
|
|
|
|
| 20-772 |
SUCRAID |
SACROSIDASE |
ORPHAN MEDCL |
1 P |
9-Apr-98 |
SOLUTION |
|
|
|
|
|
|
|
| 20-819 |
ZEMPLAR |
PARICALCITOL |
ABBOTT LAB |
1 S |
17-Apr-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-713 |
MIRCETTE |
DESOGESTREL/ ETHINYL ESTRADIOL |
ORGANON |
3 S |
22-Apr-98 |
TABLET |
|
|
|
|
|
|
|
| 20-846 |
LAMISIL |
TERBINAFINE |
NOVARTIS PHARMS |
3 S |
29-Apr-98 |
GEL |
|
|
|
|
|
|
|
| 20-896 |
XELODA |
CAPECITABINE |
HOFFMAN LA-ROCHE |
1 P |
30-Apr-98 |
TABLET |
|
|
|
|
|
|
|
| 20-809 |
DICLOFENAC SODIUM |
DICLOFENAC SODIUM |
FALCON PHARMS |
3 S |
4-May-98 |
SOLUTION |
|
|
|
|
|
|
|
| 19-781 |
PROMETRIUM |
PROGESTERONE |
SCHERING PLOUGH |
3 S |
14-May-98 |
CAPSULE |
|
|
|
|
|
|
|
| 20-912 |
AGGRASTAT |
TIROFIBAN HYDROCHLORIDE |
MERCK |
1P |
14-May-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-913 |
AGGRASTAT |
TIROFIBAN HYDROCHLORIDE |
MERCK |
3P |
14-May-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-774 |
PERIOCHIP |
CHLORHEXIDINE GLUCONATE |
PERIO PRODS |
3 S |
15-May-98 |
TABLET |
|
|
|
|
|
|
|
| 20-718 |
INTEGRILIN |
EPTIFIBATIDE |
COR |
1 P |
18-May-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-752 |
PEPCID RPD |
FAMOTIDINE |
MERCK |
3 S |
28-May-98 |
TABLET |
|
|
|
|
|
|
|
| 20-923 |
OPTIRAY |
IOVERSOL |
MALLINCKRODT MEDCL |
3 S |
29-May-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-903 |
REBETOL |
RIBAVIRIN |
SCHERING PLOUGH RES |
3 P |
3-Jun-98 |
CAPSULE |
|
|
|
|
|
|
|
| 20-838 |
ATACAND |
CANDESARTAN CILEXETIL |
ASTRA MERCK PHARMS |
1 S |
4-Jun-98 |
TABLET |
|
|
|
|
|
|
|
| 19-832 |
SULFAMYLON |
MAFENIDE ACETATE |
MYLAN PHARMS |
3 S |
5-Jun-98 |
POWDER, FOR RECONSTITUTION |
|
|
|
|
|
|
|
| 20-918 |
GLUCAGEN |
GLUCAGON HYDROCHLORIDE RECOMBINANT |
NOVO NORDISK PHARM |
3 P |
22-Jun-98 |
INJECTION |
|
|
|
|
|
|
|
| 21-024 |
PRIFTIN |
RIFAPENTINE |
HOECHST MARION RSSL |
1 P |
22-Jun-98 |
TABLET |
|
|
|
|
|
|
|
| 20-864 |
MAXALT |
RIZATRIPTAN BENZOATE |
MERCK |
1 S |
29-Jun-98 |
TABLET |
|
|
|
|
|
|
|
| 20-865 |
MAXALT |
RIZATRIPTAN BENZOATE |
MERCK |
3 S |
29-Jun-98 |
TABLET |
|
|
|
|
|
|
|
| 50-754 |
AMOXIL |
AMOXICILLIN |
SKB PHARMS |
3 S |
10-Jul-98 |
TABLET |
|
|
|
|
|
|
|
| 20-860 |
LEVLITE |
ETHINYL ESTRADIOL/ LEVONORGESTREL |
BERLEX LABS |
3 S |
13-Jul-98 |
TABLET |
|
|
|
|
|
|
|
| 20-785 |
THALOMID |
THALIDOMIDE |
CELGENE |
1 P |
16-Jul-98 |
CAPSULE |
|
|
|
|
|
|
|
| 20-822 |
CELEXA |
CITALOPRAM HYDROBROMIDE |
FOREST LABS |
1 S |
17-Jul-98 |
TABLET |
|
|
|
|
|
|
|
| 20-847 |
ESCLIM |
ESTRADIOL |
FOURNIER RES |
3 S |
4-Aug-98 |
FILM, CONTROLLED RELEASE |
|
|
|
|
|
|
|
| 20-870 |
COMBIPATCH |
ESTRADIOL/NORETHINDRONE ACETATE |
RHONE POULENC RORER |
3 S |
7-Aug-98 |
FILM, CONTROLLED RELEASE |
|
|
|
|
|
|
|
| 50-758 |
CELLCEPT |
MYCOPHENOLATE MOFETIL HYDROCHLORIDE |
GLAXOSMITHKLINE |
3 S |
12-Aug-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-764 |
LAMICTAL CD |
LAMOTRIGINE |
GLAXO WELLCOME |
3 S |
24-Aug-98 |
TABLET |
|
|
|
|
|
|
|
| 20-849 |
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER |
AMINO ACIDS |
BAXTER HLTHCARE |
3 S |
26-Aug-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-961 |
VITRAVENE PRESERVATIVE FREE |
FOMIVIRSEN SODIUM |
NOVARTIS |
1 P |
26-Aug-98 |
INJECTION |
|
|
|
|
|
|
|
| 20-946 |
PREVEN |
ETHINYL ESTRADIOL/ LEVONORGESTREL |
GYNETICS |
3 P |
1-Sep-98 |
TABLET |
|
|
|
|
|
|
|
| 50-751 |
ATRIDOX |
DOXYCYCLINE HYCLATE |
ATRIX |
3 S |
3-Sep-98 |
LIQUID, EXTENDED
RELEASE |
|
| 20-905 |
ARAVA |
LEFLUNOMIDE |
AVENTIS PHARMS |
1 P |
10-Sep-98 |
TABLET |
|
| 20-928 |
GLUCAGON |
GLUCAGON, RECOMBINANT |
LILLY |
3 P |
11-Sep-98 |
INJECTION |
|
| 20-933 |
