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Reference Listed Drug Labeling Approved in December 1999
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. Acrobat is free and available directly from Adobe's website with full installation instructions
TRADENAME |
ACTIVE/DOSAGE FORM |
NDA/SUPP# |
FIRM |
DEC |
| AMBIEN |
Zolpidem tartrate/tablet |
19-908/S-009 |
Lorex |
1 |
| CALCIJEX |
Calcitriol/injection |
18-874/S-012 |
Abbott Labs |
2 |
| CHIROCAINE |
Levobupivacaine/injection |
20-997/S-001 |
Darwin Discover |
2 |
| PARAPLATIN |
Carboplatin/for injection |
19-880/S-013 |
Bristol Myers Squibb |
3 |
| FLOXIN |
Ofloxacin/injection |
20-087/S-021 |
Johnson RW |
8 |
| FLOXIN |
Ofloxacin/tablet |
19-735/S-049 |
Johnson RW |
8 |
| TAXOL
|
Paclitaxel/injection |
20-262/S-032 |
Bristol Myers Squibb |
10 |
| CHLOROMYCETIN
|
Chloramphenicol Na succinate/for injection |
50-155/S-037 |
Parkedale |
14 |
| NIMOTOP |
Nimodipine/capsule |
18-869/S-009 |
Bayer |
15 |
| ERGAMISOL |
Levamisole HCl/tablet |
20-035/S-013 |
Janssen |
20 |
| NEORAL
|
Cyclosporine/capsule (modified) |
50-715/S-008 |
Novartis |
21 |
| NEORAL
|
Cyclosporine/oral solution (modified) |
50-716/S-012 |
Novartis |
21 |
| SANDIMMUNE
|
Cyclosporine/capsule |
50-574/S-026 |
Novartis |
21 |
| SANDIMMUNE
|
Cyclosporine/oral solution |
50-625/S-028 |
Novartis |
21 |
| SANDIMMUNE
|
Cyclosporine/injection |
50-573/S-017 |
Novartis |
21 |
| RIDAURA |
Auranofin/capsule |
18-689/S-015 |
Connetics Corp. |
22 |
| JR STR MOTRIN |
Ibuprofen/chewable tablet |
20-601/S-005 |
McNeil |
29 |
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Last Update: July 7, 2005 |
