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 |
ISUPREL |
Isoproterenol Hydrochloride Injection |
10-515 |
S-022 |
Abbott |
4-May-1999 |
PATINOL /PLATINOL-AQ |
Cisplatin For Injection/Cisplatin Injection |
18-057 |
S-068 |
Bristol Myers Squibb |
5-May-1999 |
MAXAQUIN |
Lomefolxacin Hydrochloride |
20-013 |
S-013 |
Searle |
6-May-1999 |
URACIL MUSTARD |
Uracil Mustard capsules |
12-892 |
S-001 |
Roberts Labs |
6-May-1999 |
ESTROSTEP |
Norethindrone acetate/ethinyl estadiol tablets |
20-130 |
S-003 |
Parke Davis |
7-May-1999 |
SINEMET CR |
Carbidopa And Levodopa Extended-Release Tablets |
19-856 |
S-001 |
Dupont |
10-May-1999 |
PAXIL |
Paroxetine hydrochloride tablets |
20-031 |
S-023 |
SKB Pharms |
11-May-1999 |
FORANE |
Isoflurane For Inhalation |
17-624 |
S-029 |
Baxter |
14-May-1999 |
TRI-NORINYL |
Norethindrone And Estradiol Tablets |
18-977 |
S-024 |
Searle |
14-May-1999 |
ZOVIRAX |
Acyclovir Sodium For Injection |
18-603 |
S-020 |
Glaxo Wellcome |
19-May-1999 |
CLIMARA |
Estradiol Transdermal System |
20-375 |
S-013 |
Berlex |
20-May-1999 |
FLUDARA |
Fludarabine Phosphate For Injection |
20-038 |
S-016 |
Berlex |
24-May-1999 |
BAYCOL |
Cerivastatin tablets |
20-740 |
S-002 |
Bayer |
24-May-1999 |
STADOL |
Butorphanol Tartrate Injection |
17-857 |
S-054 |
Apothecon |
25-May-1999 |
XYLOCAINE |
Lidocaine Hydrochloride Injection |
06-488 |
S-061 |
Astra |
26-May-1999 |
CYTOXAN TABLET |
Cyclophosphamide Tablets |
12-141 |
S-084 |
Bristol Myers Squibb |
28-May-1999 |
CYTOXAN INJECTION |
Cyclophophamide Injection |
12-142 |
S-102 |
Bristol Myers Squibb |
28-May-1999 |
CYLERT TABLETS |
Pemoline Tablets |
16-832 |
S-018 |
Abbott |
28-May-1999 |
CYLERT CHEWABLE TABLETS |
Pemoline Tablets (Chewable) |
17-703 |
S-016 |
Abbott |
28-May-1999 |