 |
CDER
NDA Approvals for Calendar Year
1999
Updated through December 31, 1999
| NDA Number |
Proprietary
Name |
Established
Name |
Applicant |
Chemical
Type |
Review
Classification |
Approval
Date |
| N020863 |
Pletal |
Cilostazol |
Otsuka Pharm |
1 |
S |
15-Jan-99 |
| N020781 |
Zofran ODT |
Ondansetron |
Glaxo Wellcome |
2 |
S |
27-Jan-99 |
| N020886 |
Panretin |
Alitretinoin |
Ligand |
1 |
P, O |
02-Feb-99 |
| N020900 |
Pylori-Check |
C-13 Urea |
Alimenterics |
5 |
S |
04-Feb-99 |
| N020954 |
Busulfex |
Busulfan |
Orphan Medical |
3 |
P, O |
04-Feb-99 |
| N020936 |
Paxil |
Paroxetine Hydrochloride |
SKB Pharms |
3 |
S |
16-Feb-99 |
| N020698 |
Miralax |
Polyethylene Glycol 3350 |
Braintree Labs |
3 |
S |
18-Feb-99 |
| N020955 |
Ferrlecit |
Sodium Ferric Gluconate |
R&D Labs |
1 |
P |
18-Feb-99 |
| N020969 |
Uvadex |
Methoxsalen |
Therakos |
3 |
S |
25-Feb-99 |
| N020934 |
Luxio |
Betamethasone Valerate |
Connetics |
3 |
S |
28-Feb-99 |
| N020974 |
Prozac |
Fluoxetine Hydrochloride |
Eli Lilly |
3 |
S |
09-Mar-99 |
| N020612 |
Lidoderm |
Lidocaine |
Teikoku Pharma USA |
3 |
S, O |
19-Mar-99 |
| N020992 |
Cenestin |
Synthetic Conjugated Estrogens |
Duramed Pharms |
3 |
S |
24-Mar-99 |
| N020837 |
Xopenex |
Levalbuterol Hydrochloride |
Sepracor |
3 |
S |
25-Mar-99 |
| N020908 |
Vagifem |
Estradiol |
Novo Nordisk Pharm |
3 |
S |
26-Mar-99 |
| N020966 |
Sporanox |
Itraconazole |
Janssen |
3 |
S |
30-Mar-99 |
| N021041 |
Depocyt |
Cytarabine |
Skye Pharma |
3 |
P |
01-Apr-99 |
| N020924 |
Cernevit-12 |
Multivitamins |
Baxter Healthcare |
3 |
S |
06-Apr-99 |
| N021007 |
Agenerase |
Amprenavir |
Glaxo Wellcome |
1 |
P |
15-Apr-99 |
| N021039 |
Agenerase |
Amprenavir |
Glaxo Wellcome |
3 |
P |
15-Apr-99 |
| N050760 |
Amoxil |
Amoxicillin |
SKB Pharms |
3 |
S |
15-Apr-99 |
| N050761 |
Amoxil |
Amoxicillin |
SKB Pharms |
3 |
S |
15-Apr-99 |
| N020766 |
Xenical |
Orlistat |
ROCHE |
1 |
P |
23-Apr-99 |
| N021042 |
Vioxx |
Rofecoxib |
Merck Res |
1 |
P |
20-May-99 |
| N021052 |
Vioxx |
Rofecoxib |
Merck Res |
3 |
P |
20-May-99 |
| N021071 |
Avandia |
Rosiglitazone Maleate |
SKB Pharms |
1 |
P |
25-May-99 |
| N020862 |
Hectorol |
Doxercalciferol |
Bone Care |
1 |
S |
09-Jun-99 |
| N020945 |
Norvir |
Ritonavir |
Abbott Labs |
3 |
S |
29-Jun-99 |
| N020968 |
Monistat Dual Pak |
Miconazole Nitrate |
Advanced Care Prod |
3 |
S |
30-Jun-99 |
| N021066 |
Zaditor |
Ketotifen Fumarate |
Ciba Vision |
1 |
P |
02-Jul-99 |
| N020951 |
Tagamet |
Cimetidine |
SKB Cons Healthcare |
3 |
S |
09-Jul-99 |
| N021073 |
Actos |
Pioglitazone Hydrochloride |
Takeda America |
1 |
P |
15-Jul-99 |
| N021028 |
Velosulin BR |
Human Insulin |
Novo Nordisk Pharm |
3 |
S |
19-Jul-99 |
| N021036 |
Relenza |
Zanamivir |
Glaxo Wellcome |
1 |
P |
26-Jul-99 |
| N021045 |
Levonorgestrel |
Levonorgestrel |
Womens Capital |
3 |
P |
28-Jul-99 |
| N021057 |
Antagon |
Ganirelix Acetate |
Organon |
1 |
P |
29-Jul-99 |
| N021012 |
Neo Tect Kit |
Technetium Tc-99m Depreotide |
Diatide |
1 |
P |
03-Aug-99 |
| N020902 |
Pepcid AC |
Famotidine |
Merck Res |
3 |
S |
05-Aug-99 |
| N020997 |
Chirocaine |
Levobupivacaine Hydrochloride |
Purdue Pharma LP |
2 |
S |
05-Aug-99 |
| N021029 |
Temodar |
Temozolomide |
Schering |
1 |
P, O |
11-Aug-99 |
| N020859 |
Sonanta |
Zaleplon |
Wyeth Ayerst Labs |
1 |
S |
13-Aug-99 |
| N050767 |
CLEOCIN |
Clindamycin Phosphate |
Pharmacia & Upjohn |
3 |
S |
13-Aug-99 |
| N020984 |
Raplon |
Rapacuronium Bromide |
Organon |
1 |
S |
18-Aug-99 |
| N020973 |
Aciphex |
Rabeprazole Sodium |
EISAI (US) |
1 |
S |
19-Aug-99 |
| N021083 |
Rapamune |
Sirolimus |
Wyeth Ayerst Labs |
1 |
P |
15-Sep-99 |
| N050778 |
Ellence |
Epirubicin Hydrochloride |
Pharmacia & Upjohn |
1 |
P |
15-Sep-99 |
| N021048 |
Estradiol |
Estradiol |
Wyeth Ayerst Labs |
3 |
S |
20-Sep-99 |
| N020793 |
Cafcit |
Caffeine Citrate |
OPR Develop LP |
2 |
P, O |
21-Sep-99 |
| N050747 |
Synercid |
Dalfopristin; Quinupristin |
Rhone Poulenc Rorer |
1 |
P |
21-Sep-99 |
| N050748 |
Synercid |
Dalfopristin; Quinupristin |
Rhone Poulenc Rorer |
3 |
S |
21-Sep-99 |
| N021079 |
Alamast |
Pemirolast Potassium |
Santen |
1 |
P |
24-Sep-99 |
| N020746 |
Rhinocort Aqua |
Budesonide |
Astra Pharms |
3 |
S |
01-Oct-99 |
| N020931 |
Tikosyn |
Dofetilide |
Pfizer |
1 |
S |
01-Oct-99 |
| N021019 |
Compazine |
Prochlorperazine Maleate |
SKB Pharms |
3 |
S |
06-Oct-99 |
| N021065 |
Femhrt |
Ethinyl Estradiol; Norethindrone |
Parke Davis |
3 |
S |
15-Oct-99 |
| N020796 |
Comtan |
Entacapone |
Orion |
1 |
S |
19-Oct-99 |
| N020753 |
Aromasin |
Exemestane |
Pharmacia & Upjohn |
1 |
S, O |
21-Oct-99 |
| N021040 |
Ortho-Prefest |
Estradiol; Noregestimate |
Johnson RW |
4 |
S |
22-Oct-99 |
| N021087 |
Tamiflu |
Oseltamivir Phosphate |
Roche |
1 |
P |
27-Oct-99 |
| N020744 |
Curosurf |
Poractant |
Dey Labs |
1 |
S, O |
18-Nov-99 |
| N020884 |
Aggrenox |
Aspirin; Dipyridamole |
Boehringer Ingelheim |
4 |
P |
22-Nov-99 |
| N021076 |
Aleve Cold & Sinus |
Naproxin Sodium; Pseudoephedrine Hydrochloride |
Bayer |
4 |
S |
29-Nov-99 |
| N021035 |
Keppra |
Levetiracetam |
UCB Pharma |
1 |
S |
30-Nov-99 |
| N020965 |
Levulan Kerastick |
Aminolevulinic Acid Hydrochloride |
DUSA Pharma |
1 |
S |
03-Dec-99 |
| N020990 |
Zoloft |
Sertraline Hydrochloride |
Pfizer |
3 |
S |
07-Dec-99 |
| N020937 |
Optimark |
Gadoverset Amide |
Mallinckrodt |
1 |
S |
08-Dec-99 |
| N020975 |
Optimark |
Gadoverset Amide |
Mallinckrodt |
3 |
S |
08-Dec-99 |
| N020976 |
Optimark |
Gadoverset Amide |
Mallinckrodt |
3 |
S |
08-Dec-99 |
| N021009 |
Alocril |
Nedocromil Sodium |
Allergan |
3 |
P |
08-Dec-99 |
| N020922 |
Solage |
Mequinol; Tretinoin |
Bristol Myers Squibb |
1, 4 |
S |
10-Dec-99 |
| N021085 |
Avelox |
Moxifloxacin Hydrochloride |
Bayer |
1 |
S |
10-Dec-99 |
| N021092 |
Helicosol |
C-13 Urea |
Metabolic Solution |
5 |
S |
17-Dec-99 |
| N021022 |
Penlac Nail Lacquer |
Ciclopirox |
Aventis Pharms |
3 |
S |
17-Dec-99 |
| N021038 |
Precedex |
Dexmedetomidine Hydrochloride |
Abbott Labs |
1 |
S |
17-Dec-99 |
| N021061 |
Tequin |
Gatifloxacin |
Bristol Myers Squibb |
1 |
S |
17-Dec-99 |
| N021062 |
Tequin |
Gatifloxacin |
Bristol Myers Squibb |
3 |
S |
17-Dec-99 |
| N021046 |
Celexa |
Citalopram Hydrobromide |
Forest Labs |
3 |
S |
22-Dec-99 |
| N021017 |
Humalog Mix 75/25 |
Insulin Lispro; Insulin Lispro Protamine |
Eli Lilly |
3, 4 |
S |
22-Dec-99 |
| N021018 |
Humalog Mix 50/50 |
Insulin Lispro; Insulin Lispro Protamine |
Eli Lilly |
3, 4 |
S |
22-Dec-99 |
| N021075 |
Nutropin Depot |
Somatropin |
Genentech |
3 |
P, O |
22-Dec-99 |
| N020845 |
INOmax |
Nitric Oxide |
INO Therapeutics |
1 |
P, O |
23-Dec-99 |
| N020125 |
Accuretic |
Quinapril; Hydrochlorothiazide |
Parke Davis |
4 |
S |
28-Dec-99 |
| N021055 |
Targretin |
Bexarotene |
Ligand Pharm |
1 |
P, O |
29-Dec-99 |
Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or
other noncovalent derivative
3 - New formulation
4 - New combination
5 - New manufacturer
7 - Drug already marketed, but
without an approved NDA
Review Classification:
P - Priority Review -
Significant improvement compared to marketed products, in
the treatment, diagnosis, or prevention of a disease.
S - Standard Review
- Products that do not qualify for priority review.
O - Orphan Designation -
Pursuant to Section 526 of the Orphan Drug Act (Public Law
97-414 as amended).
To access
approval letters, labels, and review packages, go to
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Date created: March 5, 2004; updated January 19, 2006
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