 |
Reference Listed Drug Labeling Approved in September 1998
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 |
| PREMARIN |
Conjugated Estrogen Tablets |
4-782 |
S-093 |
Wyeth Ayerst |
08-Sep-1998 |
| TOBI |
Tobramycin Sol |
50-753 |
S-001 |
Pathogenesis Corp |
11-Sep-1998 |
| VIRAMUNE |
Nevirapine Tablets |
20-636 |
S-009 |
Boehringer Ingelheim |
11-Sep-1998 |
| ZYFLO |
Zileuton Tablets |
20-471 |
S-007 |
Abbott Lab |
11-Sep-1998 |
| VEXOL |
Rimexolone Suspension |
20-474 |
S-007 |
Alcon |
11-Sep-1998 |
| INTEGRILIN |
Eptifibatide Injection |
20-718 |
S-001 |
Cor Therapeutics |
11-Sep-1998 |
| LOXITANE CAPSULES |
Loxapine Succinate Capsules |
17-525 |
S-049 |
Watson Labs |
16-Sep-1998 |
| LOXITANE C |
Loxapine Hcl Oral Sol. |
17-658 |
S-035 |
Watson Labs |
16-Sep-1998 |
| LOXITANE IM |
Loxapine Hcl Injection |
18-039 |
S-023 |
Watson Labs |
16-Sep-1998 |
| BIAXIN |
Clarithromycin Tablets |
50-662 |
S-020 |
Abbott |
16-Sep-1998 |
| ZERIT capsules |
Stavudine Capsules |
20-412 |
S-011 |
BMS |
16-Sep-1998 |
| ZERIT solution |
Stavudine Oral Solution |
20-413 |
S-004 |
BMS |
16-Sep-1998 |
| CIPRO TABLETS |
Ciprofloxacin Tablets |
19-537 |
S-030,031,032 |
Bayer Corp. |
17-Sep-1998 |
| CIPRO ORAL SUSPENSION |
Ciprofloxacin Oral Suspension |
20-780 |
S-001,002,003,004 |
Bayer Corp. |
17-Sep-1998 |
| CECLOR SUSPENSION |
Cefaclor For Oral Suspension |
50-522 |
S-019 |
Eli Lilly and Co. |
18-Sep-1998 |
| CECLOR PULVULE |
Cefaclor Capsules |
50-521 |
S-022 |
Eli Lilly and Co |
18-Sep-1998 |
| VENTOLIN SYRUP |
Albuterol Sulfate Syrup |
19-621 |
S-010 |
Glaxo Wellcome |
18-Sep-1998 |
| VENTOLIN NEBULES |
Albuterol Sulfate Inhalation Solution 0.083% |
19-773 |
S-010 |
Glaxo Wellcome |
18-Sep-1998 |
| VENTOLIN INHALATION SOL. |
Albuterol Sulfate Inhalation Solution 0.5% |
19-269 |
S-016 |
Glaxo Wellcome |
18-Sep-1998 |
| PHENERGAN INJECTION |
Promethazine Hcl Inj |
8-857 |
S-009 |
Wyeth-Ayerst |
18-Sep-1998 |
| FLOXIN |
Oflaxacin Tablets |
19-735 |
S-044 |
RW Johnson |
21-Sep-1998 |
| DIDRONEL |
Etidronate Injection |
19-545 |
S-005 |
MGI Pharma Inc |
22-Sep-1998 |
| Proventil HFA |
Abuterol Sulfate Inhalation Aerosol |
20-503 |
S-004 |
3M Pharmaceeuticals |
23-Sep-1998 |
| CIPRO in sodium chloride injection 0.9% |
Ciprofloxacin Injection |
19-858 |
S-020 |
Bayer Corp |
24-Sep-1998 |
CIPRO in Dextrose 5%
injection |
Ciprofloxacin Injection |
19-857 |
S-024 |
Bayer Corp |
24-Sep-1998 |
| CIPRO injection |
Ciprofloxacin Injection |
19-847 |
S-020 |
Bayer Corp |
24-Sep-1998 |
| SERVENT DISKUS |
Salmeterol Xinofoate Powder |
20-692 |
S-008 |
Glaxo Wellcome |
25-Sep-1998 |
| NEURONTIN CAPSULES |
Gabapentin Capsules |
20-235 |
S-011 |
Parke-Davis |
29-Sep-1998 |
| PRECOSE Tablets |
Acarbose Tablets |
20-482 |
S-008 |
Bayer Corp. |
29-Sep-1998 |
| ISUPREL |
Isoproterenol Hcl Inhalation Sol. |
11-178 |
S-037 |
Sanofi Winthrop |
30-Sep-1998 |
 PDF requires the free Adobe
Acrobat Reader
Date created: August 11, 1999; last update: July 7, 2005 |
|
