|
|
|
|
|
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
NDA # |
Active Ingredient | Trade Name | FDA Received Date | Approval Date | CDER Review Division | Priority | Total Time to Approval (months) | Month of FDA Review when Approval Action was Taken (time under FDA Review only) | # of Review Cycles | Deadline Approval* | Postmarketing Safety Event: New Black-Box Warning OR Safety-Based Withdrawal | Safety-Based Withdrawal Date | New Black-Box Warning Addition Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
020815 |
Raloxifene Hydrochloride |
Evista |
09-Jun-97 |
09-Dec-97 |
510 |
P |
6.0 |
6 |
1 |
Y |
Y |
|
13-Sep-07 |
021071 |
Rosiglitazone Maleate |
Avandia |
25-Nov-98 |
25-May-99 |
510 |
P |
6.0 |
6 |
1 |
Y |
Y |
|
14-Aug-07 |
021073 |
Pioglitazone Hydrochloride |
Actos |
15-Jan-99 |
15-Jul-99 |
510 |
P |
6.0 |
6 |
1 |
Y |
Y |
|
14-Aug-07 |
020998 |
Celecoxib |
Celebrex |
30-Jun-98 |
31-Dec-98 |
170 |
P |
6.0 |
6 |
1 |
Y |
Y |
|
29-Jul-05 |
020896 |
Capecitabine |
Xeloda |
31-Oct-97 |
30-Apr-98 |
150 |
P |
6.0 |
6 |
1 |
Y |
Y |
|
07-Sep-01 |
020564 |
Lamivudine |
Epivir |
07-Jul-95 |
17-Nov-95 |
530 |
P |
4.4 |
5 |
1 |
Y |
Y |
|
15-Dec-97 |
020720 |
Troglitazone |
Rezulin |
01-Aug-96 |
29-Jan-97 |
510 |
P |
6.0 |
6 |
1 |
Y |
Y |
22-Mar-00 |
15-Dec-97 |
021042 |
Rofecoxib |
Vioxx |
23-Nov-98 |
20-May-99 |
170 |
P |
5.9 |
6 |
1 |
Y |
Y |
30-Sep-04 |
|
021341 |
Valdecoxib |
Bextra |
16-Jan-01 |
16-Nov-01 |
170 |
S |
10.0 |
10 |
1 |
Y |
Y |
06-Apr-05 |
24-Nov-04 |
020759 |
Trovafloxacin Mesylate |
Trovan |
30-Dec-96 |
18-Dec-97 |
590 |
S |
11.6 |
12 |
1 |
Y |
Y |
|
09-Jun-99 |
020760 |
Alatrofloxacin Mesylate |
Trovan |
30-Dec-96 |
18-Dec-97 |
590 |
S |
11.6 |
12 |
1 |
Y |
Y |
|
09-Jun-99 |
020740 |
Cerivastatin Sodium |
Baycol |
26-Jun-96 |
26-Jun-97 |
510 |
S |
12.0 |
12 |
1 |
Y |
Y |
08-Aug-01 |
|
020695 |
Grepafloxacin Hydrochloride |
Raxar |
08-Nov-96 |
06-Nov-97 |
590 |
S |
11.9 |
12 |
1 |
Y |
Y |
27-Oct-99 |
|
021107 |
Alosetron Hydrochloride |
Lotronex |
30-Jun-99 |
09-Feb-00 |
180 |
P |
7.4 |
8 |
1 |
|
Y |
28-Nov-00 |
07-Jun-02 |
020628 |
Saquinavir |
Invirase |
31-Aug-95 |
06-Dec-95 |
530 |
P |
3.2 |
4 |
1 |
|
Y |
|
14-Nov-00 |
020315 |
Levomethadyl Acetate Hydrochloride |
Orlaam |
21-Jun-93 |
09-Jul-93 |
170 |
P |
0.6 |
1 |
1 |
|
Y |
23-Aug-03 |
|
021200 |
Tegaserod Maleate |
Zelnorm |
11-Feb-00 |
24-Jul-02 |
180 |
P |
29.4 |
17 |
3 |
|
Y |
30-Mar-07 |
|
021064 |
Perflutren Lipid Microsphere |
Definity |
09-Dec-98 |
31-Jul-01 |
160 |
S |
31.7 |
22 |
3 |
|
Y |
|
10-Oct-07 |
020937 |
Gadoversetamide |
Optimark |
02-Mar-98 |
08-Dec-99 |
160 |
S |
21.2 |
16 |
2 |
|
Y |
|
04-Sep-07 |
021144 |
Telithromycin |
Ketek |
01-Mar-00 |
01-Apr-04 |
520 |
S |
49.1 |
27 |
3 |
|
Y |
|
12-Feb-07 |
020639 |
Quetiapine Fumarate |
Seroquel |
29-Jul-96 |
26-Sep-97 |
130 |
S |
13.9 |
14 |
2 |
|
Y |
|
20-Sep-06 |
020592 |
Olanzapine |
Zyprexa |
22-Sep-95 |
30-Sep-96 |
130 |
S |
12.3 |
12 |
2 |
|
Y |
|
16-Feb-06 |
021436 |
Aripiprazole |
Abilify |
31-Oct-01 |
15-Nov-02 |
130 |
S |
12.5 |
12 |
2 |
|
Y |
|
16-Feb-06 |
021302 |
Pimecrolimus |
Elidel |
15-Dec-00 |
13-Dec-01 |
540 |
S |
11.9 |
12 |
1 |
|
Y |
|
19-Jan-06 |
021411 |
Atomoxetine Hydrochloride |
Strattera |
12-Oct-01 |
26-Nov-02 |
130 |
S |
13.5 |
12 |
2 |
|
Y |
|
08-Nov-05 |
020825 |
Ziprasidone Hydrochloride |
Geodon |
17-Mar-97 |
05-Feb-01 |
130 |
S |
46.7 |
25 |
3 |
|
Y |
|
17-Aug-05 |
020938 |
Meloxicam |
Mobic |
16-Dec-98 |
13-Apr-00 |
170 |
S |
15.9 |
14 |
2 |
|
Y |
|
11-Aug-05 |
020822 |
Citalopram Hydrobromide |
Celexa |
12-May-97 |
17-Jul-98 |
130 |
S |
14.2 |
14 |
2 |
|
Y |
|
18-Feb-05 |
021427 |
Duloxetine Hydrochloride |
Cymbalta |
13-Nov-01 |
03-Aug-04 |
130 |
S |
32.7 |
24 |
3 |
|
Y |
|
18-Feb-05 |
020415 |
Mirtazapine |
Remeron |
30-Jan-95 |
14-Jun-96 |
130 |
S |
16.5 |
15 |
2 |
|
Y |
|
12-Jan-05 |
020169 |
Nilutamide |
Nilandron |
07-Mar-94 |
19-Sep-96 |
150 |
S |
30.5 |
24 |
3 |
|
Y |
|
29-Sep-00 |
020697 |
Tolcapone |
Tasmar |
05-Jun-96 |
29-Jan-98 |
120 |
S |
19.8 |
18 |
2 |
|
Y |
|
16-Nov-98 |
020535 |
Bromfenac Sodium |
Duract |
30-Dec-94 |
15-Jul-97 |
170 |
S |
30.5 |
24 |
3 |
|
Y |
22-Jun-98 |
31-Mar-98 |
020430 |
Danaparoid Sodium |
Orgaran |
30-Dec-94 |
24-Dec-96 |
160 |
S |
23.8 |
20 |
3 |
|
Y |
|
30-Jan-98 |
020689 |
Mibefradil Dihydrochloride |
Posicor |
11-Mar-96 |
20-Jun-97 |
110 |
S |
15.3 |
15 |
2 |
|
Y |
08-Jun-98 |
|
020984 |
Rapacuronium Bromide |
Raplon |
25-Jun-98 |
18-Aug-99 |
170 |
S |
13.8 |
12 |
2 |
|
Y |
27-Mar-01 |
|
021462 |
Pemetrexed Disodium |
Alimta |
30-Sep-03 |
04-Feb-04 |
150 |
P |
4.2 |
5 |
1 |
Y |
|
|
|
020961 |
Fomivirsen Sodium |
Vitravene |
09-Apr-98 |
26-Aug-98 |
520 |
P |
4.6 |
5 |
1 |
Y |
|
|
|
050794 |
Azacitidine |
Vidaza |
29-Dec-03 |
19-May-04 |
150 |
P |
4.7 |
5 |
1 |
Y |
|
|
|
020666 |
Albendazole |
Albenza |
11-Dec-95 |
11-Jun-96 |
590 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021066 |
Ketotifen Fumarate |
Zaditor |
04-Jan-99 |
02-Jul-99 |
560 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
021057 |
Ganirelix Acetate |
Antagon |
29-Jan-99 |
29-Jul-99 |
580 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
020560 |
Alendronate Sodium |
Fosamax |
31-Mar-95 |
29-Sep-95 |
510 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021756 |
Pegaptanib Sodium |
Macugen |
17-Jun-04 |
17-Dec-04 |
520 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021084 |
Perfluoroalkylpolyether;Polytetrafluoroethylene |
Skin Exposure Reduction Paste Against Chemical Warfare Agents |
19-Aug-99 |
17-Feb-00 |
540 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021007 |
Amprenavir |
Agenerase |
16-Oct-98 |
15-Apr-99 |
530 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021130 |
Linezolid |
Zyvox |
18-Oct-99 |
18-Apr-00 |
520 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021214 |
Unoprostone Isopropyl |
Rescula |
15-Feb-00 |
03-Aug-00 |
520 |
P |
5.6 |
6 |
1 |
Y |
|
|
|
050722 |
Mycophenolate Mofetil |
Cellcept |
10-Nov-94 |
03-May-95 |
590 |
P |
5.7 |
6 |
1 |
Y |
|
|
|
021248 |
Arsenic Trioxide |
Trisenox |
28-Mar-00 |
25-Sep-00 |
150 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021227 |
Caspofungin Acetate |
Cancidas |
28-Jul-00 |
26-Jan-01 |
590 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021275 |
Bimatoprost |
Lumigan |
18-Sep-00 |
16-Mar-01 |
520 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
021567 |
Atazanavir Sulfate |
Reyataz |
20-Dec-02 |
20-Jun-03 |
530 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021356 |
Tenofovir Disoproxil Fumarate |
Viread |
01-May-01 |
26-Oct-01 |
530 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
020412 |
Stavudine |
Zerit |
28-Dec-93 |
24-Jun-94 |
530 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
021449 |
Adefovir Dipivoxil |
Hepsera |
21-Mar-02 |
20-Sep-02 |
530 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021549 |
Aprepitant |
Emend |
27-Sep-02 |
26-Mar-03 |
180 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
021498 |
Nitazoxanide |
Alinia |
29-May-02 |
22-Nov-02 |
590 |
P |
5.8 |
6 |
1 |
Y |
|
|
|
021087 |
Oseltamivir Phosphate |
Tamiflu |
29-Apr-99 |
27-Oct-99 |
530 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021797 |
Entecavir |
Baraclude |
29-Sep-04 |
29-Mar-05 |
530 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021821 |
Tigecycline |
Tygacil |
15-Dec-04 |
15-Jun-05 |
520 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
020741 |
Repaglinide |
Prandin |
01-Jul-97 |
22-Dec-97 |
510 |
P |
5.7 |
6 |
1 |
Y |
|
|
|
021814 |
Tipranavir |
Aptivus |
22-Dec-04 |
22-Jun-05 |
530 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
020702 |
Atorvastatin Calcium |
Lipitor |
17-Jun-96 |
17-Dec-96 |
510 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
020671 |
Topotecan Hydrochloride |
Hycamtin |
22-Dec-95 |
28-May-96 |
150 |
P |
5.2 |
6 |
1 |
Y |
|
|
|
021779 |
Iloprost |
Ventavis |
30-Jun-04 |
29-Dec-04 |
110 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
020571 |
Irinotecan Hydrochloride |
Camptosar |
28-Dec-95 |
14-Jun-96 |
150 |
P |
5.6 |
6 |
1 |
Y |
|
|
|
021024 |
Rifapentine |
Priftin |
22-Dec-97 |
22-Jun-98 |
590 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021688 |
Cinacalcet Hydrochloride |
Sensipar |
08-Sep-03 |
08-Mar-04 |
510 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
020905 |
Leflunomide |
Arava |
10-Mar-98 |
10-Sep-98 |
170 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021079 |
Pemirolast Potassium |
Alamast |
26-Mar-99 |
24-Sep-99 |
520 |
P |
6.0 |
6 |
1 |
Y |
|
|
|
021481 |
Enfuvirtide |
Fuzeon |
16-Sep-02 |
13-Mar-03 |
530 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
020977 |
Abacavir Sulfate |
Ziagen |
24-Jun-98 |
17-Dec-98 |
530 |
P |
5.8 |
6 |
1 |
Y |
|
|
|
020895 |
Sildenafil Citrate |
Viagra |
29-Sep-97 |
27-Mar-98 |
580 |
P |
5.9 |
6 |
1 |
Y |
|
|
|
021197 |
Cetrorelix Acetate |
Cetrotide |
29-Oct-99 |
11-Aug-00 |
580 |
S |
9.4 |
10 |
1 |
Y |
|
|
|
021565 |
Epinastine Hydrochloride |
Elestat |
20-Dec-02 |
16-Oct-03 |
520 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021372 |
Palonosetron Hydrochloride |
Aloxi |
27-Sep-02 |
25-Jul-03 |
180 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021176 |
Colesevelam Hydrochloride |
Welchol |
30-Jul-99 |
26-May-00 |
510 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021487 |
Memantine Hydrochloride |
Namenda |
19-Dec-02 |
16-Oct-03 |
120 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021500 |
Emtricitabine |
Emtriva |
03-Sep-02 |
02-Jul-03 |
530 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021773 |
Exenatide |
Byetta |
30-Jun-04 |
28-Apr-05 |
510 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021445 |
Ezetimibe |
Zetia |
27-Dec-01 |
25-Oct-02 |
510 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021437 |
Eplerenone |
Inspra |
29-Nov-01 |
27-Sep-02 |
110 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021035 |
Levetiracetam |
Keppra |
01-Feb-99 |
30-Nov-99 |
120 |
S |
9.9 |
10 |
1 |
Y |
|
|
|
021654 |
Omega-3-Acid Ethyl Esters |
Omacor |
12-Jan-04 |
10-Nov-04 |
510 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
021782 |
Ramelteon |
Rozerem |
22-Sep-04 |
22-Jul-05 |
120 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
021629 |
Insulin Glulisine |
Apidra |
18-Jun-03 |
16-Apr-04 |
510 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
021667 |
L-Glutamine |
NutreStore |
11-Aug-03 |
10-Jun-04 |
180 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
021455 |
Ibandronate Sodium |
Boniva |
16-Jul-02 |
16-May-03 |
510 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
020753 |
Exemestane |
Aromasin |
21-Dec-98 |
21-Oct-99 |
150 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
021618 |
Tinidazole |
Tindamax |
17-Jul-03 |
17-May-04 |
590 |
S |
10.0 |
10 |
1 |
Y |
|
|
|
020688 |
Olopatadine Hydrochloride |
Patanol |
29-Jan-96 |
18-Dec-96 |
520 |
S |
10.7 |
11 |
1 |
Y |
|
|
|
020478 |
Sevoflurane |
Ultane |
11-Jul-94 |
07-Jun-95 |
170 |
S |
10.9 |
11 |
1 |
Y |
|
|
|
020629 |
Penciclovir |
Denavir |
16-Oct-95 |
24-Sep-96 |
530 |
S |
11.3 |
12 |
1 |
Y |
|
|
|
020459 |
Nalmefene Hydrochloride |
Revex |
29-Apr-94 |
17-Apr-95 |
170 |
S |
11.6 |
12 |
1 |
Y |
|
|
|
020682 |
Miglitol |
Glyset |
29-Dec-95 |
18-Dec-96 |
510 |
S |
11.7 |
12 |
1 |
Y |
|
|
|
020677 |
Sparfloxacin |
Zagam |
27-Dec-95 |
19-Dec-96 |
590 |
S |
11.8 |
12 |
1 |
Y |
|
|
|
020835 |
Risedronate Sodium |
Actonel |
01-Apr-97 |
27-Mar-98 |
510 |
S |
11.8 |
12 |
1 |
Y |
|
|
|
020625 |
Fexofenadine Hydrochloride |
Allegra |
31-Jul-95 |
25-Jul-96 |
570 |
S |
11.8 |
12 |
1 |
Y |
|
|
|
020665 |
Valsartan |
Diovan |
28-Dec-95 |
23-Dec-96 |
110 |
S |
11.9 |
12 |
1 |
Y |
|
|
|
020664 |
Cabergoline |
Dostinex |
27-Dec-95 |
23-Dec-96 |
580 |
S |
11.9 |
12 |
1 |
Y |
|
|
|
020696 |
Fomepizole |
Antizol |
06-Dec-96 |
04-Dec-97 |
170 |
S |
11.9 |
12 |
1 |
Y |
|
|
|
020829 |
Montelukast Sodium |
Singulair |
21-Feb-97 |
20-Feb-98 |
570 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020864 |
Rizatriptan Benzoate |
Maxalt |
30-Jun-97 |
29-Jun-98 |
120 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020363 |
Famciclovir |
Famvir |
30-Jun-93 |
29-Jun-94 |
530 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020768 |
Zolmitriptan |
Zomig |
26-Nov-96 |
25-Nov-97 |
120 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020771 |
Tolterodine Tartrate |
Detrol |
25-Mar-97 |
25-Mar-98 |
580 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020482 |
Acarbose |
Precose |
06-Sep-94 |
06-Sep-95 |
510 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020613 |
Brimonidine Tartrate |
Alphagan |
07-Sep-95 |
06-Sep-96 |
520 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020726 |
Letrozole |
Femara |
25-Jul-96 |
25-Jul-97 |
150 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
020579 |
Tamsulosin Hydrochloride |
Flomax |
15-Apr-96 |
15-Apr-97 |
580 |
S |
12.0 |
12 |
1 |
Y |
|
|
|
021492 |
Oxaliplatin |
Eloxatin |
24-Jun-02 |
09-Aug-02 |
150 |
P |
1.5 |
2 |
1 |
|
|
|
|
020685 |
Indinavir Sulfate |
Crixivan |
31-Jan-96 |
13-Mar-96 |
530 |
P |
1.4 |
2 |
1 |
|
|
|
|
021335 |
Imatinib Mesylate |
Gleevec |
27-Feb-01 |
10-May-01 |
150 |
P |
2.4 |
3 |
1 |
|
|
|
|
020779 |
Nelfinavir Mesylate |
Viracept |
26-Dec-96 |
14-Mar-97 |
530 |
P |
2.6 |
3 |
1 |
|
|
|
|
020659 |
Ritonavir |
Norvir |
21-Dec-95 |
01-Mar-96 |
530 |
P |
2.3 |
3 |
1 |
|
|
|
|
021751 |
Pentetate Zinc Trisodium |
Pentetate Zinc Trisodium |
28-Apr-04 |
11-Aug-04 |