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 |
| SINGULAIR |
Montelukast Sodium Chewable Tablet |
20-830 |
S-006 |
Merck Res |
1-Dec-1998 |
| SINGULAIR |
Montelukast Sodium Tablet |
20-829 |
S-006 |
Merck Res |
1-Dec-1998 |
| TRUSOPT |
Dorzolamide Hydrochloride |
20-408 |
S-015 |
Merck |
1-Dec-1998 |
| LOPID |
Gemfibrozil Tablet |
18-422 |
S-034 |
Parke Davis |
3-Dec-1998 |
| CLARITIN-D 24 HOUR |
Loratadine/Pseudoephedrine Sulfate Extended-Release Tablet |
20-470 |
S-005 |
Schering Corp |
4-Dec-1998 |
| AVAPRO |
Irbesartan Tabs 75/150/300mg Tablet |
20-757 |
S-006 |
Sanofi Pharms |
8-Dec-1998 |
| LUVOX |
Fluvoxamine Maleate |
20-243/ |
S-015 |
Solvay |
8-Dec-1998 |
| DIURIL TABLETS AND ORAL SUSPENSION |
Chlorthiazide tablet
Chlorthiazide oral suspension |
11-145
11-870 |
S-085
S-031 |
Merck &Co. |
9-Dec-1998 |
| TRIDIL INJECTION |
Nitroglycerine Injection |
18-537 |
S-015 |
Faulding |
9-Dec-1998 |
| EFFEXOR |
Venlafaxine Hydrochloride |
20-151 |
S-009 |
Wyeth Ayerst |
9-Dec-1998 |
| NITROGLYCERIN IN DEXTROSE |
Nitroglycerin |
19-970 |
S-009 |
Baxter Hlthcare |
9-Dec-1998 |
| REBETOL |
Interferon Alfa-2b, Recombinant Capsules |
20-903 |
S-002 |
Schering Plough Res |
9-Dec-1998 |
| BRETHINE INJECTION |
Terbutaline Sulfate Injection |
18-571 |
S-005 |
Novartis |
11-Dec-1998 |
| CARNITOR |
Levocarnitine |
20-182
19-257
18-948 |
|
Sigma Tau |
15-Dec-1998 |
| ALTACE |
Ramipril Capsule |
19-901 |
S-025 |
King Pharms |
16-Dec-1998 |
| SULAR |
Nisoldipine |
20-356 |
S-009 |
Zeneca |
16-Dec-1998 |
| PEDIAPRED SOLUTION |
Prednisolone Sodium Phosphate Oral Solution |
19-157 |
S-011 |
Medeva |
17-Dec-1998 |
| CHILDREN'S/JUNIOR STRENGTH MOTRIN CHEWABLE TABLETS |
Ibuprofen Tablets 50 and100 mg |
20-601 |
S-003 |
McNeil |
18-Dec-1998 |
| CHILDREN'S MOTRIN SUSPENSION |
Ibuprofen Suspension 100mg/5ml |
20-516 |
S-003 |
McNeil |
18-Dec-1998 |
| FLOVENT |
Fluticasone Propionate Aerosol |
20-548 |
S-008 |
Glaxo Wellcome |
22-Dec-1998 |
| VIAGRA |
Sildenafil Citrate Tab |
20-895 |
S-004 |
Pfizer, Inc. |
22-Dec-1998 |
| NICORETTE |
Nicotene Polacrilex Gum 2mg And 4 mg |
18-612
20-066 |
S-025
S-007 |
Smithkline Beecham |
23-Dec-1998 |
| SEREVENT |
Salmeterol Xinafoate |
20-236 |
S-017 |
Glaxo Wellcome |
24-Dec-1998 |
| BSS PLUS IRRIGATION SOLUTIONS |
Enriched Balanced Salt Solution |
18-469 |
S-032 |
Alcon |
29-Dec-1998 |
