Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes. Click on the product name to view the approved labeling changes in Adobe Acrobat format
Product Name |
Established Name |
NDA No. |
Supp. No. |
Firm |
Date |
| BRETHINE |
Terbutaline Sulfate Tablet |
17-849 |
032 |
Novartis Pharms |
2-Feb-1999 |
| CHLOROMYCETIN |
Chloramphenicol Opth Ointment |
50-156 |
038 |
Parkedale |
3-Feb-1999 |
| PRILOSEC |
Omeprazole Delayed-Release Capsule |
19-810 |
057 |
Astra Merck |
3-Feb-1999 |
| TRANSDERM-NITRO |
Nitroglycerin Transdermal System |
20-144 |
018 |
Novartis Pharms |
3-Feb-1999 |
| PRIMAXIN |
Cilastatin Sodium/Imipenem Injection |
50-587
50-630 |
050 |
Merck |
4-Feb-1999 |
| SUS-PHRINE |
Epinephrine Injection |
07-942 |
016 |
Forest Labs |
5-Feb-1999 |
| AZMACORT |
Triamcinolone Acetonide MDI |
18-117 |
029 |
Rhone Poulenc Rorer |
8-Feb-1999 |
| MAXIPIME |
Cefepime HCl Injection |
50-679 |
005 |
Bristol Myers Squibb |
8-Feb-1999 |
| VANCERIL |
Beclomethasone Dipropionate |
17-573 |
040 |
Schering |
8-Feb-1999 |
| CEREZYME |
Imiglucerase For Injection |
20-367 |
027 |
Genzyme |
11-Feb-1999 |
| FURADANTIN |
Nitrofurantoin Suspension |
09-175 |
020 |
Dura |
11-Feb-1999 |
| SINGULAIR |
Montelukast Sodium Chewable Tablet |
20-830
20-829 |
001 |
Merck Res |
12-Feb-1999 |
| ASTELIN |
Azelastine HCl Spray |
20-114 |
002 |
Wallace Labs |
16-Feb-1999 |
| AZACTAM |
Aztreonam Injection |
50-580 |
028,031 |
Bristol Myers Squibb |
16-Feb-1999 |
| AZACTAM |
Aztreonam Injection |
50-632 |
009 |
E R Squibb |
16-Feb-1999 |
| CEDAX |
Ceftibuten Suspension |
50-685
50-686 |
006 |
Schering Plough |
16-Feb-1999 |
| DOBUTAMINE HCL IN DEXTROSE |
Dobutamine HCl Injection |
20-269
20-201 |
006 |
Abbott |
17-Feb-1999 |
| IMDUR |
Isosorbide Mononitrate Tablet |
20-225 |
007 |
Schering |
17-Feb-1999 |
| NITRO-DUR |
Nitroglycerin Transdermal System |
20-145 |
011 |
Key Pharms |
17-Feb-1999 |
| PRINZIDE |
Hydrochlorothiazide/Lisinopril Tablet |
19-778 |
029 |
Merck |
17-Feb-1999 |
| RHINOCORT |
Budesonide MDI |
20-233 |
006 |
Astra Pharms |
17-Feb-1999 |
| TECZEM |
Diltiazem Malate/Enalapril Mal Tablet |
20-507 |
001 |
Merck |
17-Feb-1999 |
| VASERETIC |
Enalapril Maleate/Hctz Tablet |
19-221 |
025 |
Merck |
17-Feb-1999 |
| VASOTEC |
Enalapril Maleate Tablet |
18-998 |
057 |
Merck |
17-Feb-1999 |
| VASOTEC IV |
Enalaprilat Injection |
19-309 |
022 |
Merck |
17-Feb-1999 |
| ZOFRAN IN PLASTIC |
Ondansetron HCl Dihydrate Injection |
20-403 |
008 |
Glaxo Wellcome |
17-Feb-1999 |
| ZOFRAN |
Ondansetron HCl Injection |
20-007 |
028 |
Glaxo Wellcome |
17-Feb-1999 |
| ZOFRAN PRESERVATIVE |
Ondansetron HCl Injection |
20-007 |
028 |
Glaxo Wellcome |
17-Feb-1999 |
| VERSED |
Midazolam HCl Injection |
18-654 |
024,028,036 |
Roche |
19-Feb-1999 |
| ARTHROTEC |
Diclofenac Sodium/Misoprostol Delayed-Release Tablet |
20-607 |
004 |
Searle |
22-Feb-1999 |
| DIFLUCAN |
Fluconazole Fror Oral Solution |
20-090 |
011 |
Pfizer |
22-Feb-1999 |
| DIFLUCAN |
Fluconazole Tablet |
19-949 |
027 |
Pfizer |
22-Feb-1999 |
| DIFLUCAN IN DEXTROSE |
Fluconazole Injection |
19-950 |
028 |
Pfizer |
22-Feb-1999 |
| PITOCIN |
Oxytocin Injection |
18-261 |
013 |
Parkedale |
22-Feb-1999 |
| PREVACID |
Lansoprazole Delayed-Release Capsule |
20-406 |
030 |
Tap Holdings |
22-Feb-1999 |
| ZYBAN |
Bupropion HCl Extended-Release Tablet |
20-711 |
002,004 |
Glaxo Wellcome (Us) |
24-Feb-1999 |
| NICOTROL INHALER |
Nicotine Inhaler |
20-714 |
005 |
Pharmacia And Upjohn |
25-Feb-1999 |
| AMIDATE |
Etomidate Injection |
18-227 |
012 |
Abbott Labs |
26-Feb-1999 |
| TUBOCURARINE CHLORIDE |
Tubocurarine Chloride Injection |
06-095 |
034,038 |
Abbott Labs |
26-Feb-1999 |
