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 |
| ANAFRANIL |
Clomipramine Hydrochloride Capsules |
19-906 |
022 |
Novartis Pharms |
4-Jan-1999 |
| BAYCOL |
Cerivastatin Tablets |
20-740 |
003 |
Bayer |
4-Jan-1999 |
| COSOPT |
Dorzolamide HCl/Timolol Maleate opth. Sol. |
20-869 |
001 |
Merck Res |
4-Jan-1999 |
| LESCOL |
Fluvastatin Sodium Capsule |
20-261 |
019 |
Novartis Pharm |
4-Jan-1999 |
| CORDARONE |
Amiodarone Hydrochloride Tablets 200 mg |
18-972 |
017 |
Wyeth Ayerst Labs |
5-Jan-1999 |
| LAMISIL |
Terbinafine HCl Tablets |
20-539 |
003 |
Novartis Pharms |
5-Jan-1999 |
| LOESTRIN FE 1.5/30 |
Ethinyl Estradiol/Norethindrone Tablets |
17-355 |
043 |
Parke Davis |
8-Jan-1999 |
| LOESTRIN FE 1/20 |
Ethinyl Estradiol/Norethindrone Tablets |
17-354 |
041 |
Parke Davis |
8-Jan-1999 |
| MODICON-28 |
Ethinyl Estradiol/Norethindrone Tablets |
17-735 |
084 |
RW Johnson |
6-Jan-1999 |
| ORTHO-NOVUM-28 |
Ethinyl Estradiol/Norethindrone Tablets |
17-919 |
066 |
RW Johnson |
6-Jan-1999 |
| TAXOL |
Paclitaxel Injection |
20-262 |
031 |
Bristol Myers Squibb |
8-Jan-1999 |
| ZYPREXA |
Olanzapine Tablets |
20-592 |
010 |
Lilly |
11-Jan-1999 |
| ALDACTAZIDE |
Spironolactone/Hydrochlorothiazide Tablets |
12-616 |
061 |
Searle Pharms |
13-Jan-1999 |
| ALDACTONE |
Spironolactone Tablets |
12-151 |
059 |
Searle |
13-Jan-1999 |
| MONOKET |
Isosorbide Mononitrate Tablets
Isosorbide Mononitrate Extended-release Capsules |
20-215
19-215 |
008
007 |
Schwarz Pharma |
13-Jan-1999 |
| NITROLINGUAL |
Nitroglycerin Lingual Aerosol Spray |
18-705 |
008 |
Pohl Boskamp |
13-Jan-1999 |
| NICOTROL |
Nicotine Inhaler |
20-714 |
003 |
Pharmacia And Upjohn |
14-Jan-1999 |
| PREVACID |
Lansoprazole Delayed-release Capsule |
20-406 |
027 |
Tap Holdings |
14-Jan-1999 |
| CAVERJECT |
Alprostadil Injection |
20-379 |
010 |
Pharmacia And Upjohn |
20-Jan-1999 |
| PEPCID RPD |
Famotidine Orally Disintingrating Tablets |
20-752 |
001 |
Merck Res |
20-Jan-1999 |
| ANZEMET |
Dolasetron Mesylate Injection |
20-623
20-624 |
002
002 |
Hoechst Marion Rssl
|
25-Jan-1999
|
| SORBITRATE |
Isosorbide DinitrateTablets |
16-776
16-192 |
036
043 |
Zeneca |
26-Jan-1999 |
| WELLBUTRIN SR |
Bupropion Hydrochloride Extended-release Tablets |
20-358 |
002 |
Glaxo Wellcome |
26-Jan-1999 |
| MAXIPIME |
Cefepime Hydrochloride Injection |
50-679 |
007 |
Bristol Myers Squibb |
27-Jan-1999 |
| QUELICIN |
Succinylcholine Chloride Injection |
08-845 |
049 |
Abbott Labs |
29-Jan-1999 |
