New!  As of May 1, 2004, New and Generic Drug Approvals 1998-2004, will not be updated. 
Please use Drugs@FDA for all drug approval information, which includes the content of this page.

 

Product Name Company Application # Approval
Date

Letter
Posted

Label
Posted 		Review
Posted
Factive (gemifloxacin mesylate) Tablets, 320 mg, Rx GeneSoft Pharmaceuticals NDA 21-158/S1 7/25/03 8/15/03 8/15/03  
Factive (gemifloxacin mesylate) Tablets, 320 mg, Rx LG Life Sciences, Ltd NDA 21-158 4/4/03 4/18/03 4/18/03 9/24/03
Factrel (gonadorelin HCl),  Wyeth Pharmaceuticals NDA 18-123/SCS-014 7/19/02 7/24/02    
Famotidine Injection, 10 mg/mL, Rx   Apotex Corp. ANDA 76-324 11/27/02
Famotidine Injection, 10 mg/mL, Rx   Apotex Corp. ANDA 76-322 11/27/02
Famotidine Injection, 10 mg/mL, 4mL & 20 mL vials, Rx   Apotex Corp. ANDA 75-942 8/2/02      
Famotidine Injection, 10 mg/mL, Rx   Abbott Laboratories ANDA 75-905 11/23/01  4/17/03    
Famotidine Injection, 10 mg/mL, Rx   Abbott Laboratories ANDA 75-870 11/23/01  4/17/03    
Famotidine Injection, 10 mg/mL, Rx   Ben Venue Laboratories, Inc. ANDA 75-825 4/17/01 4/24/01    
Famotidine Injection, 10 mg/mL (Preservative-Free), Rx Tentatively approved 1/25/2001 Ben Venue Laboratories, Inc. ANDA 75-825 1/25/01 3/5/01    
Famotidine Injection, 10 mg/mL, Rx   American Pharmaceutical Partners, Inc. ANDA 75-813 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL (4 mL and 20 mL Multi-dose vials, Rx   Baxter Pharmaceutical Products Inc. ANDA 75-799 4/30/02      
Famotidine Injection (Preservative Free, 10 mg/mL (2 mL vial, Rx   Baxter HealthCare Corporation ANDA 75-789 4/30/02      
Famotidine Injection, 0.4 mg/mL & 50 mL, Rx   Abbott Laboratories ANDA 75-729 12/17/01      
Famotidine Injection, 10 mg/mL & 20 mL, Rx   American Pharmaceutical Partners, Inc. ANDA 75-709 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL & 20 mL, Rx  Tentative Approval American Pharmaceutical Partners, Inc. ANDA 75-709 2/28/01 3/6/01    
Famotidine Injection, 10 mg/mL, Rx   Apothecon Inc. ANDA 75-708 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, Rx  Tentative Approval Apothecon Inc. ANDA 75-708 2/7/01 3/6/01    
Famotidine Injection, 10 mg/mL, Rx   Apothecon Inc. ANDA 75-707 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, Rx  Tentative Approval Apothecon Inc. ANDA 75-707 3/13/01 3/30/01    
Famotidine Injection, 10 mg/mL, Rx Faulding Pharmaceutical Co. ANDA 75-705 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, Rx Tentatively approved 12/12/2000 Faulding Pharmaceutical Co. ANDA 75-705 12/12/00 3/5/01    
Famotidine Injection, 10 mg/mL, Rx   Bedford Laboratories ANDA 75-684 4/16/01 4/24/01   12/17/01
Famotidine Injection, 10 mg/mL, Rx Tentatively approved 1/24/2001 Bedford Laboratories ANDA 75-684 1/24/01 3/5/01    
Famotidine Injection, 10 mg/mL (Preservative-Free), Rx Faulding Pharmaceutical Co. ANDA 75-669 4/16/01 4/24/01   12/17/01
Famotidine Injection, 10 mg/mL (Preservative-Free), Rx Tentatively approved 12/12/2000 Faulding Pharmaceutical Co. ANDA 75-669 12/12/00 3/5/01    
Famotidine Injection, 10 mg/mL, (Preservative Free), Rx Bedford Laboratories ANDA 75-651 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, (Preservative Free), Rx Bedford Laboratories ANDA 75-622 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, (Preservative Free), Rx Tentatively approved 12/26/2000 Bedford Laboratories ANDA 75-622 12/26/00 3/5/01    
Famotidine Injection, 0.4 mg/mL (20 mg/50 mL), Rx   Baxter Healthcare Corp. ANDA 75-591 5/10/01 6/5/01
Famotidine Injection, 10 mg/mL, 4 mL and 20 mL multiple-dose vials (Preserved), Rx   ESI Lederle ANDA 75-488 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, 4 mL and 20 mL multiple-dose vials (Preserved), Rx Tentatively approved 12/20/2000 ESI Lederle ANDA 75-488 12/20/00 3/5/01    
Famotidine Injection, 10 mg/mL, 2 mL vials (Preservative-Free), Rx ESI Lederle ANDA 75-486 4/16/01 4/24/01    
Famotidine Injection, 10 mg/mL, 2 mL vials (Preservative-Free) Tentatively approved 12/20/2000 ESI Lederle ANDA 75-486 12/20/00 3/5/01    
Famotidine Injection, 10 mg/mL, 2 mL vial (Preservative-Free) Tentatively approved 11/20/1998 Marsam Pharmaceuticals Inc. ANDA 75-194 11/20/98 11/20/98    
Famotidine Injection,10 mg/mL, Pharmacy bulk package (Preservative-Free), Tentatively approved Nov. 30, 1998 Marsam Pharmaceuticals Inc. ANDA 75-193 11/30/98 12/1/98    
Famotidine Injection, 10 mg/mL, 4 mL and 20 mL Multiple-Dose Vials Tentatively approved 11/20/1998 Marsam Pharmaceuticals Inc. ANDA 75-192 11/20/98 11/20/98    
Famotidine Tablets USP, 10 mg, OTC Eon labs Inc. ANDA 76-101 10/21/02
Famotidine Tablets USP, 10 mg,  Tentatively Approved Eon labs Manufacturing, Inc. ANDA 76-101 9/14/01  4/16/03    
Famotidine Tablets USP, 10 mg Tentatively Approved TEVA Pharmaceuticals ANDA 75-821 2/12/04      
Famotidine Tablets USP,20 & 40 mg, Rx Carlsbad Technology Inc. ANDA 75-805 4/16/01 4/24/01    
Famotidine Tablets USP,20 & 40 mg, Rx Eon Labs Manufacturing, Inc. ANDA 75-793 4/16/01 4/24/01    
Famotidine Tablets USP, 20 mg and 40 mg, Rx  Wockhardt Americas, Inc. ANDA 75-786 4/16/01 4/24/01    
Famotidine Tablets USP, 20 mg and 40 mg, Rx Tentatively Approved 3/28/01 Wockhardt Americas, Inc. ANDA 75-786 3/28/01 3/30/01    
Famotidine Tablets USP, 10 mg, OTC Dr. Reddy's Laboratories Ltd. ANDA 75-758 8/17/01      
Famotidine Tablets USP, 10 mg, OTC Tentatively Approved 12/13/00 Cheminor Drugs Limited ANDA 75-758 12/13/00 3/5/01    
Famotidine Tablets USP,20 mg and 40 mg, Rx Tentatively approved 11/29/00 Cheminor Drugs Limited ANDA 75-718 11/29/00 3/5/01    
Famotidine Tablets USP,20 mg and 40 mg, Rx  Reddy-Cheminor Inc. ANDA 75-718 4/16/01 4/24/01    
Famotidine Tablets USP,20 mg and 40 mg, Rx Tentatively approved 7/27/00 Reddy-Cheminor Inc. ANDA 75-718 7/27/00 11/7/00    
Famotidine Tablets USP, 10 mg, Rx L.Perrigo Company ANDA 75-715 8/22/03  
Famotidine Tablets USP,20 mg and 40 mg, Rx Mylan Pharmaceuticals, Inc. ANDA 75-704 4/16/01 4/24/01    
Famotidine Tablets USP,20 mg and 40 mg, Rx Tentatively approved 2/6/2001 Mylan Pharmaceuticals, Inc. ANDA 75-704 2/6/01 3/5/01    
Famotidine Tablets USP, 10 mg, OTC Genpharm Inc. ANDA 75-674 12/21/01      
Famotidine Tablets USP, 10 mg, OTC Tentatively Approved Genpharm Inc. ANDA 75-674 10/12/01      
Famotidine Tablets USP, 20 mg and 40 mg, Rx Purepac Pharmaceutical Co. ANDA 75-650 9/14/01 4/14/03 5/1/02 5/1/02
Famotidine Tablets USP,20 mg and 40 mg, Rx Tentatively approved 3/17/2000 Purepac Pharmaceutical Co. ANDA 75-650 3/17/00 3/21/00    
Famotidine Tablets USP, 20 mg & 40 mg, Rx Mutual Pharmaceutical Company, Inc. ANDA 75-639 12/12/01      
Famotidine Tablets USP,20 mg & 40 mg, Rx (tentatively Approved 3/16/00) Apothecon, Inc. ANDA 75-628 3/16/00 3/21/00    
Famotidine Tablets USP, 10 mg, Rx  Torpharm ANDA 75-610 3/12/02 4/10/03    
Famotidine Tablets USP, 20 mg and 40 mg, Rx  Invamed Inc. ANDA 75-607 5/10/01 6/5/01
Famotidine Tablets USP, 20 mg and 40 mg, Rx  TorPharm ANDA 75-611 7/23/01      12/24/03
Famotidine Tablets USP, 20 mg and 40 mg, Rx  Zenith Goldline Pharmaceuticals, Inc. ANDA 75-511 4/16/01 4/24/01    
Famotidine Tablets USP, 20 mg and 40 mg, Rx  Tentatively approved February 18, 2000 Zenith Goldline Pharmaceuticals, Inc. ANDA 75-511 2/18/00      
Famotidine Tablets USP, 20 mg & 40 mg, Rx,  Genpharm Inc. ANDA 75-457 4/18/01 4/24/01    
Famotidine Tablets USP, 20 mg & 40 mg, Rx, Tentatively approved 4/26/2000 Genpharm Inc. ANDA 75-457 4/26/00 4/28/00    
Famotidine Tablets USP, 10 mg, Rx Danbury Pharmacal, Inc. ANDA 75-404 11/28/01 4/14/03    
Famotidine Tablets USP, 10 mg, Rx, Tentatively approved Jun. 04, 1999 Danbury Pharmacal, Inc. ANDA 75-404 6/4/99 6/11/99    
Famotidine Tablets USP, 10 mg, Rx, Tentatively approved L. Perrigo Co. ANDA 75-400 3/25/02 4/10/03    
Famotidine Tablets USP, 10 mg, Rx, TEVA Pharmaceuticals ANDA 75-312 5/31/01 6/5/01    
Famotidine Tablets USP, 10 mg, Rx, Tentatively approved 10/15/1998 TEVA Pharmaceuticals ANDA 75-312 10/15/98 10/26/98    
Famotidine Tablets USP, 20 mg and 40 mg, Rx TEVA Pharmaceuticals ANDA 75-311 4/16/01 4/24/01 1/3/02 1/3/02
Famotidine Tablets USP, 20 mg and 40 mg, Rx, Tentatively approved Oct. 15, 1998 TEVA Pharmaceuticals ANDA 75-311 10/15/98 10/26/98    
Famotidine Tablets USP, 20 mg and 40 mg, Rx Geneva Pharmaceuticals, Inc. ANDA 75-302 4/16/01 4/24/01    
Famotidine Tablets USP, 20 mg and 40 mg, Rx, Tentatively Approved Geneva Pharmaceuticals, Inc. ANDA 75-302 2/5/01 2/28/01    
Famotidine Tablets USP, 20 mg and 40 mg, Rx, Tentatively Approved Geneva Pharmaceuticals, Inc. ANDA 75-302 8/30/99 9/2/99    
Famotidine Tablets USP, 20 mg and 40 mg,Rx Danbury Pharmacal ANDA 75-062 4/16/01 4/24/01    
Famotidine Tablets USP, 20 mg and 40 mg,Rx , Tentatively Approved 10/28/1998 Danbury Pharmacal ANDA 75-062 10/28/98 10/28/98    
Famotidine Tablets USP, 20 mg and 40 mg, Rx, Tentatively approved October 28, 1998 Novopharm Limited ANDA 74-687 10/28/98 10/29/98    
Famvir (famciclovir) Tablets, Novartis Pharmaceuticals Corporation  NDA 20-363/SLR-019 3/27/01 5/1/01   4/14/04
Famvir (famciclovir) Tablets, 125mg, 250mg, & 500mg SmithKline Beecham NDA 20-363/S-010/S-014/S-016 6/12/98 1/6/99    
  Famvir Indication:  for the treatment of recurrent mucocutaneous herpes simplex infections in HIV-infected patients.
Famvir (famciclovir) Tablets Novartis Pharmaceuticals Corporation NDA 20-363/SLR-019 3/27/01 4/27/01 4/27/01  
Fansidar (sulfadoxine and pyrimethamine) Tablets, 500 mg/25 mg, Rx Hoffmann-La Roche Inc. NDA 18-557/S-016 4/27/03  
Fansidar (sulfadoxine and pyrimethamine) Tablets, 500 mg/25 mg, Rx Hoffmann-La Roche Inc. NDA 18-557/S15 2/26/04 3/3/04 4/5/04  
FASLODEX (fulvestrant) Injection, Rx AstraZeneca Pharmaceuticals NDA 21-344/S1 12/24/03 1/14/04 1/15/04  
FASLODEX (fulvestrant) Injection, Rx AstraZeneca Pharmaceuticals NDA 21-344 4/25/02 5/2/02 4/25/02 6/25/02
Fazaclo (Clozapine) Orally Disintegrating Tablets, 25 & 100mg, Rx Alamo Pharmaceuticals NDA 21-590 2/9/04 3/3/04 4/5/04
Felbatol (Felbamate) Tablets & Oral Suspension, Rx Wallace Pharmaceuticals NDA 20-189/S18 11/19/02 11/22/02
Feldene (piroxicam) Capsules, 10 mg, Rx Pfizer Pharmaceuticals Group NDA 18-147/S-028 1/8/03 1/23/03
Felodipine Extended-Release Tablets, 2.5, 5 & 10mg, Rx Tentative Approval Mutual Pharmaceutical Co. ANDA 75-896 2/6/04
Femara (letrozole) Tablets, 2.5 mg, Rx Novartis NDA 20-726/S8 1/17/03 1/23/03 1/23/03
Femara (letrozole) Tablets, Rx Novartis NDA 20-726/S-006 1/10/01 1/16/01 1/16/01 7/12/01
Femara (letrozole) Tablets, Rx Novartis NDA 20-726/S-005 2/26/03 3/10/03 3/11/03
  Femara Indications:  Fisrt-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer.
Femhrt (norethindrone acetate/ethinyl estradiol), Tablets, Rx Galen (Chemicals) Limited NDA 21-065/S9 1/20/04 1/22/04 1/22/04
Femhrt (norethindrone acetate and ethinyl estradiol), tablets, Rx [patient information] Parke-Davis NDA 21-065 10/15/99 12/30/99 12/30/99 6/19/01
Femring (estradiol acetate vaginal ring),  Galen Limited NDA 21-367 3/20/03 3/26/03 3/26/03 7/16/03
Femstat One (butoconazole nitrate) Vaginal Cream, 2%, Rx KV Pharmaceutical Company NDA 19-881/S-002 4/30/03  
Fenofibrate Capsules (Micronized), 67 mg, Rx  Novopharm Limited ANDA 75-753 9/3/02      
Fenofibrate Capsules (Micronized), 134 & 200 mg, Rx (67 mg, strength remains Tentatively Approved) Novopharm Limited ANDA 75-753 4/9/02 4/10/03    
Fenofibrate Capsules (Micronized), 67, 134, & 200 mg, Rx IMPAX Laboratories, Inc. ANDA 75-868 10/27/03
Fenofibrate Tablets, 54 & 160 mg, Rx Tentatively Approved Impax Pharmaceuticals ANDA 76-506 3/5/04
Fenofibrate Tablets, 54 & 160 mg, Rx Tentatively Approved TEVA Pharmaceuticals ANDA 76-433 3/5/04
Fenofibrate Capsules (Micronized), 67, 134, & 200 mg, Rx Tentatively Approved IMPAX Laboratories, Inc. ANDA 75-868 2/20/02 4/10/03    
Fenoldopam Mesylate Injection, 10 & 20 mg, Rx PharmaForce ANDA 76-656 12/1/03
Fentanyl Citrate Injection USP, 0.05 mg (base)/mL Marsam Pharmaceuticals, Inc. ANDA 74-917 2/3/98     3/16/99
Fentanyl Transdermal System, Rx Mylan Technologies ANDA 76-258 11/21/03
Ferrlecit (sodium ferric gluconate complex in sucrose injection), Rx R&D Laboratories NDA 20-955/S5 6/7/02 6/17/02    
Ferrlecit (sodium ferric gluconate complex in sucrose injection), Rx  Watson Pharmaceutical, Inc., and R&D Laboratories, Inc. NDA 20-955/S-003 02/02/01 7/23/03 04/25/03
Ferrlecit (sodium ferric gluconate complex in sucrose injection) R&D Laboratories NDA 20-955 2/18/99 2/19/99 2/19/99  5/24/01
  Ferrlecit Indication: Treatment of iron deficiency anemia in patients undergoing
chronic hemodialysis who are receiving supplemental erythropoetin therapy.
Fexofenadine HCI & Pseudoephedrine HCI Extended-Release Tablets, 60mg/120mg, Rx Tentatively Approved Impax Laboratories, Inc. ANDA 76-298 2/27/04
FINACEA (azelaic acid) Gel, 15%, Rx Berlex Drug Development and Technology NDA 21-470 12/24/02 1/30/03 4/9/03 3/24/04
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate) Capsules,  Novartis Pharmaceuticals Corporation NDA 19-429/S-006 8/26/02 8/30/02
Flagyl (metronidazole), Rx Pfizer NDA 12-623/S59 3/17/04 3/23/04 4/7/04
Flagyl 375 (metronidazole), Rx Pfizer NDA 20-334/S3 4/17/04 3/23/04 4/7/04
Flagyl 375 (metronidazole) Capsules, Rx Pharmacia NDA 20-334/S-001 4/23/03
Flagyl ER (metronidazole), Rx Pfizer NDA 20-868/S6 3/17/04 3/23/04 4/7/04
Flagyl ER (metronidazole) Extended-Release Capsules, Rx Pharmacia NDA 20-868/S5 4/23/03
Flagyl (metronidazole) tablets, Rx Pharmacia NDA 12-623/S-058 4/23/03
Flavoxate Hydrochloride Tablets, 100 mg, Rx Impax Laboratories, Inc. ANDA 76-234 8/28/03  
Flecainide Acetate Tablets USP, 50, 100  & 150 mg, Rx Ranbaxy Laboratories ANDA 76-421 3/28/03
Flecainide Acetate Tablets USP, 50, 100  & 150 mg, Rx Roxane Laboratories, Inc. ANDA 76-278 1/14/03
Flecainide Acetate Tablets USP, 50, 100  & 150 mg, Rx Geneva Pharmaceuticals Technology Corp ANDA 76-030 10/28/02      
Flecainide Acetate Tablets USP, 50, 100  & 150 mg, Rx Tentatively Approved Geneva Pharmaceuticals Technology Corp ANDA 76-030 8/20/01  4/16/03    
Flecainide Acetate Tablets USP, 50 mg, 100 mg & 150 mg, Rx Barr Laboratories, Inc. ANDA 75-882 10/28/02      
Flecainide Acetate Tablets USP, 50 mg, 100 mg & 150 mg, Rx, 2nd Tentative Approval  Barr Laboratories, Inc. ANDA 75-882 4/26/02      
Flecainide Acetate Tablets USP, 50 mg, 100 mg & 150 mg, Rx, Tentatively Approved 7/31/2001 Barr Laboratories, Inc. ANDA 75-882 7/31/01      
Flecainide Acetate Tablets USP, 50 mg, 100 mg & 150 mg, Rx Alphapharm Pty. Ltd. ANDA 75-442 7/31/01      
Flexeril (cyclobenzaprine HCL) Tablets, 5 mg, Rx McNeil Consumer and Specialty Pharmaceuticals NDA 17-821/S-045 2/3/03 2/12/03 2/13/03
Flolan (epoprostenol sodium) Injection, Rx Glaxo Wellcome NDA 20-444/S-003 4/14/00 4/17/00 4/17/00 1/7/02
  Flolan Indication:  Long-term intravenous treatment of pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III & Class IV patients who do not respond to conventional therapy.
Flonase Nasal Spray, Flovent Inhalation Aerosol & Rotadisk, Rx GlaxoSmithKline NDA 20-121/S30, 20-548/S20 & 20-549/S16 3/26/04 4/7/04 4/7/04  
Flonase Nasal Spray, 50 mcg, Rx GlaxoSmithKline NDA 20-121/S28 5/1/03 7/9/03    
Flonase Nasal Spray, 50 mcg, Rx GlaxoSmithKline, Inc. NDA 20-121/S23 5/23/02 6/3/02    
Flonase (fluticasone propionate) Nasal Spray, Rx GlaxoSmithKline, Inc. NDA 20-121/S11, S13, & S20 5/9/02 5/21/02    
Flonase (fluticasone propionate) Nasal Spray, 50 mcg, Rx GlaxoWellcome NDA 20-121/S-009 12/11/98 12/14/98   9/14/01
  Flonase Indication:    For perennial nonallergic rhinitis for ages 4 and above.
Florone (diflorasone diacetate) Cream, 0.05% Pharmacia & Upjohn NDA 17-741/S22 12/18/03 12/22/03 12/29/03
Florone (diflorasone diacetate cream) Cream, 0.05% Pharmacia & Upjohn Company NDA 17-741/S-021 5/29/03 7/8/03
Flovent (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline NDA 20548/S19 10/8/03  10/16/03  10/16/03
Flovent (fluticasone propionate) Inhalation Aerosol, GlaxoSmithKline NDA 20548/S015/16 6/20/03 7/6/03 7/8/03
Flovent (fluticasone propionate inhalation powder) Rotadisk, GlaxoSmithKline NDA 20548/S14 10/8/03  
Flovent (fluticasone propionate inhalation powder) Rotadisk Glaxo Wellcome Inc. NDA 20548/S008 & 20-549/S-002 12/22/98 5/23/01
Flovent (fluticasone propionate inhalation powder) Rotadisk Glaxo Wellcome Inc. NDA 20549/S-014 10/8/03 10/16/03 10/16/03 5/23/01
Flovent (Fluticasone Propionate) Inhalation Powder Rotadisk GlaxoSmithKline NDA 20-549/S11/S12 6/20/03 7/6/03 7/8/03  
Flovent (fluticasone dipropionate inhalation powder) Rotadisk Glaxo Wellcome Inc. NDA 20-549/S-006 7/19/99 5/23/01
Flovent (fluticasone propionate inhalation powder) Rotadisk Glaxo Wellcome Inc. NDA 20-549/S-008 3/29/01    
Flovent Diskus (fluticasone dipropionate inhalation powder). Glaxo Wellcome Inc. NDA 20-833/S-002 11/1/02 11/18/02
Flovent Diskus (fluticasone dipropionate inhalation powder). GlaxoSmithKline NDA 20-833/S-008 11/1/02 11/18/02
Flovent Diskus (fluticasone dipropionate) inhalation powder, 50mcg, 100mcg, 250mcg, Rx GlaxoWellcome NDA 20-833 9/29/00 10/10/00    
  Indication:  This new drug application provides for the use of Flovent Diskus 50 mcg, Flovent Diskus 100 mcg and Flovent Diskus 250 mcg (fluticasone propionate) Inhalation Powder for the maintenance treatment of asthma as prophylactic therapy in adults and pediatric patients 4 years of age and older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of these patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.
Floxin (Ofloxacin) Otic Solution, Rx Daiichi Pharmaceutical NDA 20-799/S15 2/24/04 2/25/04
Floxin (Ofloxacin) Otic Solution, Rx Daiichi Pharmaceutical NDA 20-799/S12 10/7/03 10/9/03 10/10/03
Floxin (Ofloxacin) Otic Solution, Rx Daiichi Pharmaceutical NDA 20-799/S-006 9/30/03 10/9/03 10/10/03
Floxin (Ofloxacin) Otic Solution, Rx Daiichi Pharmaceutical NDA 20-799 9/30/03
Floxin (Ofloxacin) Tablets, Rx R.W. Johnson Pharmaceutical NDA 19-735/S51 3/6/04 3/10/04 4/7/04
Floxuridine Injection USP, 500 mg/vial, Rx American Pharmaceutical Partners, Inc. ANDA 75-837 2/22/01 3/6/01    
Floxuridine Injection USP, 500 mg/vial, Rx Bedford Laboratories ANDA 75-387 4/6/00 4/13/00    
Fluconazole Injection, Rx (Tentatively Approved) SICOR Pharmaceuticals ANDA 76-653 12/24/03
Fluconazole Injection, Rx (Tentatively Approved) Faulding Pharmaceutical ANDA 76-617 10/30/03
Fluconazole Injection, 200mg/100mL & 400mg/200mL, Rx (Tentatively Approved 4/15/03) American Pharmaceutical Partners, Inc. ANDA 76-145 4/15/03
Fluconazole Injection, 2 mg/mL, Rx Tentatively Approved Bedford Laboratories ANDA 76-087 7/17/03
Fluconazole Injection, 2mg/mL, (IN 5% DEXTROSE INJECTION), Tentatively Approved Abbott ANDA 76-304 6/18/03      
Fluconazole Injection, 2mg/mL, (IN 0.9% SODIUM CHLORIDE INJECTION), Tentatively Approved Abbott ANDA 76-303 6/18/03      
Fluconazole Oral Suspension, 10 mg/mL and 40 mg/mL, Rx Tentatively Approved Ranbaxy Pharmaceuticals ANDA 76-332 7/11/03  
Fluconazole Oral Suspension, 10 mg/mL and 40 mg/mL, Rx (Tentatively Approved 4/18/03) Roxane Laboratories, Inc. ANDA 76-246 4/18/03
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, Rx (Tentatively Approved) Taro Pharmaceuticals ANDA 76-507 11/12/03  
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, Rx (Tentatively Approved) Gedeon Richter ANDA 76-432 9/25/03  
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, Rx (Tentatively Approved) Pliva, Inc. ANDA 76-424 5/9/03  
Fluconazole Tablets, 50 mg, 100 mg, 150 mg, & 200 mg, Rx (Tentatively Approved) Ranbaxy Laboratories ANDA 76-386 5/1/03