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
Bacitracin Injection, 50,000 units/vial, Rx American Pharmaceutical Partners ANDA 65-116 12/3/02      
Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Rx Altana, Inc. ANDA 65-022 2/27/02      
Baclofen Injection, 0.05mg/ml, Rx Medtronic Neurological NDA 20-075/S-019 1/17/03 1/23/03    
Bacteriostatic Sodium Chloride Injection, 9%, Rx Abbott Laboratories NDA 18-800/S-014 2/19/03 7/9/03    
Bacteriostatic Sodium Chloride Injection, 9%, Rx Abbott Laboratories NDA 18-800/S-011 5/16/03      
Bacteriostatic Sodium Chloride Injection, 9%, Rx Abbott Laboratories NDA 18-800 S-014 2/19/03 2/25/03    
Bactrim (trimethoprim and sulfamethoxazole) Tablets and DS (double strength) Tablets,  Women First HealthCare NDA 17-377/S-058 10/17/02 10/21/02 10/18/02  
Bactrim (trimethoprim and sulfamethoxazole) Tablets,  Women First HealthCare NDA 17-377/S-057 2/12/03 2/14/03 2/14/03  
Bactroban Ointment (mupirocin), 2% SmithKline Beecham NDA 50-591/S-22 4/99 4/27/99   7/12/00
Balziva-28 (Norethindrone & Ethinyl Estradiol) Tablets, Barr Laboratories ANDA 76-238 4/22/04      
Balziva-21 (Norethindrone & Ethinyl Estradiol) Tablets, Barr Laboratories ANDA 76-198 4/22/04      
Banan (cefpodoxime proxetil) Tablets and Suspension Sankyo Pharma Inc. NDA: 50-687/SE8-004, SE1-007, SE2-010, SE2-011
NDA: 50-688/SE8-006, SE1-008, SE2-011, SE2-012		 2/10/00 2/14/00   7/18/01
Bayer Extra Strength Aspirin Migraine (Acetylsalicylic Acid) Tablets, 500 mg Bayer Corp. NDA 21-317 10/24/01 11/6/01 2/6/02 2/6/02
Baycol (cerivastatin) Tablets, 0.4 mg, Rx
Withdrawn from market 8/8/01		 Bayer Corporation NDA 20-740/S-002 5/25/99 5/26/99   11/29/01
Baycol (cerivastatin) Tablets, Rx
Withdrawn from market 8/8/01		 Bayer Corporation NDA 20-740/S-003 1/4/99     11/29/01
Baycol (cerivastatin) Tablets, Rx
Withdrawn from market 8/8/01		 Bayer Pharmaceutical Division NDA 20-740/S6 3/30/01 4/25/01 4/25/01 12/3/01
Baycol (cerivastatin) Tablets, 0.8 mg, Rx
Withdrawn from market 8/8/01		 Bayer Pharmaceutical Division NDA 20-740/S-008, S-013 7/23/00 7/25/00   11/29/01
  Withdrawn from market 8/8/01. Baycol Indication:  S-008- reduction of elevated LDL-C in a new, higher strength tablet, 0.8mg, and for extension of the dosage range to 0.8mg daily.
S-013- increasing HDL-cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemias.  
Baycol (cerivastatin) Tablets, Rx
Withdrawn from market 8/8/01		 Bayer Corporation NDA 20-740/S14 11/6/00     12/3/01
Baycol (cerivastatin) Tablets, Rx
Withdrawn from market 8/8/01		 Bayer Pharmaceutical Division NDA 20-740/S18 5/10/01   5/10/01 12/3/01
Baycol (cerivastatin) Tablets, Rx
Withdrawn from market 8/8/01		 Bayer Pharmaceutical Division NDA 20-740/S19 5/21/01   5/21/01 12/3/01
Beconase (beclomethasone dopropionate) Nasal Aerosol, Rx GlaxoSmithKline NDA 18-584/S-026 12/16/02 1/29/03    
Beconase AQ (beclomethasone dopropionate) Nasal Spray, Rx GlaxoSmithKline NDA 19-389/S-025 12/16/02 1/29/03    
Beconase AQ (beclomethasone dopropionate) Nasal Spray, Rx GlaxoSmithKline NDA 19-389/S-021 12/19/02 1/29/03    
Benadryl (diphenhydramine hydrochloride) Injection, Pfizer Inc. NDA 9-486/S-028 10/24/03 11/5/03    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Genpharm, Inc. ANDA 76-476 2/11/04      
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Mylan Pharmaceuticals ANDA 76-430 2/11/04 2/27/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Mylan Pharmaceuticals ANDA 76-430 1/23/04      
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Eon Labs, Inc. ANDA 76-402 2/11/04 2/27/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Eon Labs, Inc. ANDA 76-402 2/26/03      
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Ranbaxy ANDA 76-344 2/11/04 2/12/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Ranbaxy Pharmaceuticals, Inc. ANDA 76-344 2/26/03      
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Ivax Pharmaceuticals ANDA 76-333 2/11/04 2/12/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Genpharm, Inc.
 		 ANDA 76-476 2/11/04 2/12/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Andrx Pharmaceuticals ANDA 76-267 2/11/04 2/12/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Andrx Pharmaceuticals ANDA 76-267 2/26/03      
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Teva Pharmaceuticals ANDA 76-211 2/11/04 2/12/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Teva Pharmaceuticals ANDA 76-211 11/7/03      
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx KV Pharmaceutical ANDA 76-118 2/11/04 2/12/04    
Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved KV Pharmaceutical ANDA 76-118 11/7/03      
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Rx Mylan Pharmaceuticals ANDA 76-688 2/11/04 2/12/04    
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Rx Eon Labs, Inc. ANDA 76-631 2/11/04 2/12/04    
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Rx Genpharm, Inc.
 		 ANDA 76-612 2/11/04 2/12/04    
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Rx IVAX Pharmaceuticals, Inc.
 		 ANDA 76-348 2/11/04 2/12/04    
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Rx Andrx Pharmaceuticals ANDA 76-342 2/11/04 2/12/04    
Benazepril Hydrochloride & Hydrochlorothiazide Tablets, Rx Tentatively Approved Andrx Pharmaceuticals ANDA 76-342 9/30/03      
Benicar HCT Tablets, Rx Sankyo Pharma, Inc. NDA 21-532 6/5/03 6/9/03 6/9/03 9/10/03
Benicar (olmesartan medoxomil) Tablets, 5, 20, and 40 mg, Rx Sankyo Pharma, Inc. NDA 21-286/S2 2/12/03 2/25/03    
Benicar (olmesartan medoxomil) Tablets, 5, 20, and 40 mg, Rx Sankyo Pharma, Inc. NDA 21-286/S1 10/25/02 10/28/02    
Benicar (olmesartan medoxomil) Tablets, 5, 20, and 40 mg, Rx Sankyo Pharma, Inc. NDA 21-286 4/25/02 5/2/02 4/25/02 7/5/02
Benoquin (monobenzone) Cream, 20%, Rx ICN Pharmaceuticals, Inc. NDA 8-173/S-015 3/26/03 4/15/03 4/1/03  
Bentyl (dicyclomine hydrocholride) Injection,  Aventis Pharmaceuticals NDA 8-370/S-030 8/12/02 8/21/02    
BenzaClin Topical Gel, Rx Dermik Laboratories NDA 50-756/S7 8/9/02 8/14/02 8/9/02  
BenzaClin Topical Gel, Rx Dermik Laboratories NDA 50-756 12/21/00     11/20/02
  BenzaClin Indications:  Acne vulgaris.
Benzamycin (erythromycin, 3% and benzoyl peroxide, 5%) Topical Gel,  Dermik Laboratories, Inc. NDA 50-557/S25 1/27/03 1/30/03 1/30/03  
Benzamycin Pak (erythromycin 3%-benzoyl peroxide 5% topical gel),Rx Dermik Laboratories, Inc. NDA 50-769 11/27/00     2/4/04
  Benzamycin Indication:  for acne vulgaris
Betagan (levobunolol HCI Liquidfilm) Allergan NDA 19-219/S20 8/8/01   4/15/03  
Betagan (levobunolol HCl) liquifilm Allergan NDA 19-814/S12 8/8/01   6/10/03  
Betagan (levobunolol HCl) liquifilm Allergan NDA 19-814/S11 5/14/01   6/10/03  
Betamethasone Dipropionate Cream, 0.05% (base), Rx Atrix Laboratories ANDA 76-603 1/24/04      
Betamethasone Dipropionate Cream, 0.05% (base), Rx Clay-Park Labs ANDA 76-592 12/9/03      
Betamethasone Dipropionate Cream, 0.05% (base), Rx Taro Pharmaceuticals ANDA 76-543 12/9/03      
Betamethasone Dipropionate Cream, 0.05% (base), Rx Altana Inc. ANDA 76-215 12/9/03      
Betamethasone Dipropionate Cream, 0.05% (base), Rx Tentative Approval Altana Inc. ANDA 76-215 1/15/03      
Betamethasone Dipropionate Ointment USP (Augmented), 0.05% (base). Altana Inc. ANDA 75-373 6/22/99 6/22/99   1/17/02
Betamethasone Dipropionate Gel, 0.05% (base), Rx Taro Pharmaceuticals ANDA 76-508 12/2/03      
Betamethasone Dipropionate Gel, 0.05% (base), Rx Altana Inc. ANDA 75-276 5/13/03     12/23/2003
Betamethasone Dipropionate Gel, 0.05% (base), Rx Tentative Approval Altana Inc. ANDA 75-276 2/28/03      
Betapace (sotalol hydrochloride) Tablets, 80, 120, 160, & 240 mg, Rx Berlex NDA 19-865/S10 10/1/01 6/19/02 6/19/02 6/19/02
Betapace AF (sotalol hydrochloride) Tablets, Rx Berlex Laboratories NDA 21-151/S5 4/2/03 4/18/03    
Betapace AF (sotalol hydrochloride) Tablets, Rx Berlex Laboratories NDA 21-151/S4 3/14/03 3/26/03    
Betapace AF (sotalol hydrochloride) Tablets, Rx Berlex Laboratories NDA 21-151 2/22/00 2/24/00 2/24/00  
  Betapace AF Indication: Maintenance of normal sinus rhythm [delay in time to recurrence of atrial fibrillation/atrial flutter (AFIB/AFL) in patients with symptomatic AFIB/AFL who are currently in sinus rhythm. Because Betapace AF can cause life-threatening ventricular arrhythmias, it should be reserved for patients in whom AFIB/AFL is highly symptomatic.   Patients with paroxysmal AFIB/AFL that is easily reversed should usually not be given Betapace AF.
Betaseron
Interferon beta-1b


 

 

 Chiron Corp BLA 103471 / 5032 10/10/03 10/31/03 10/31/03  
Betaxolol Hydrochloride Tablets USP, 10 mg and 20 mg. Amide Pharmaceutical, Inc. ANDA 75-541 10/22/99 12/29/99    
Betaxolol Ophthalmic Solution USP, 0.5%, Rx Bausch & Lomb Pharmaceuticals, Inc. ANDA 75-630 4/12/01 4/13/01    
Betaxolol Ophthalmic Solution USP, 0.5%, Rx, Tentatively approved Bausch & Lomb Pharmaceuticals, Inc. ANDA 75-630 4/19/00 4/24/00    
Betaxolol Ophthalmic Solution USP, 0.5%, Rx Novex Pharma ANDA 75-446 9/28/00 10/30/00    
Betaxolol Ophthalmic Solution USP, 0.5%, Rx, Tentatively approved Akorn, Inc. ANDA 75-386 4/25/00      
Betaxolol Ophthalmic Solution USP, 0.5%, Rx Akorn, Inc. ANDA 75-386 6/30/00 10/30/00    
Betaxon (levobetaxolol hydrochloride ophthalmic suspension),0.5%, Rx Alcon Universal,Limited NDA 21-114   2/29/00    
  Betaxon Indication: for lowering intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension. Dosage form/route of administration is new
Bethanechol Chloride Tablets, 50 mg, Rx Wockhardt ANDA 40-518 9/29/03      
Bethanechol Chloride Tablets, 5 mg, Rx Wockhardt ANDA 40-532 9/29/03      
Bethanechol Chloride Tablets, 10 mg, Rx Wockhardt ANDA 40-533 9/29/03      
Bethanechol Chloride Tablets, 25 mg, Rx Wockhardt ANDA 40-534 9/29/03      
Bethine & Brethine (terbutaline sulfate) Tablets & Injection, aaiPharma NDA 17-849/S39 & 18-571/S19 12/19/03 12/23/03    
Betoptic S (betaxolol HCl ophthalmic suspension), 0.25%, Rx Alcon Laboratories NDA 19-845/S-017 5/9/03 7/9/03    
Bextra (Valdecoxib) Tablets, Rx Pfizer NDA 21-341/S3 4/23/04      
Bextra (Valdecoxib) Tablets, Rx Pharmacia Corporation NDA 21-341/S2 11/1/02 11/18/02    
Bextra (Valdecoxib) Tablets, Rx G.D. Searle & Co. NDA 21-341 11/16/01 5/30/02 5/30/02 5/30/02
  Bextra Indications:  for the relief of the signs and symptoms of osteoarthritis, adult rheumatoid arthritis and for treatment of primary dysmmenorrhea.
Biaxin Filmtab and BiaxinŽ Granules,  Abbott Laboratories NDA 50-697/S2 & 50-698/S14 5/24/02 6/17/02    
BIAXIN XL Tablets (clarithromycin extended-release) Abbott Laboratories NDA 50-775 3/3/00 3/7/00 3/7/00 10/11/01
BIAXIN XL Filmtab (clarithromycin) Extended-release Tablets, 500 mg, Rx Abbott Laboratories NDA 50-775/S4 4/11/03 4/18/03    
BIAXIN XL Filmtab (clarithromycin) extended-release Abbott Laboratories NDA 50-775/S1 8/3/01 11/5/01 11/5/01 11/23/01
  Biaxin XL Indication:  for Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis
Biaxin (clarithromycin tablets, USP) Filmtab, Rx Abbott Laboratories NDA 50-662/S30 & S31 6/6/02 6/17/02    
Biaxin (clarithromycin) Filmtab, 250 mg, Rx Abbott Laboratories NDA 50-662/S029 10/20/00 10/30/00 10/30/00 11/23/01
  Biaxin XL Indication:  provides for the addition of Haemophilus influenzae to the previously approved indication of Community-Acquired Pneumonia for Biaxin Filmtab (clarithromycin tablets).
Biaxin (clarithromycin) Filmtab, Granules Abbott Laboratories NDA 50-775/S 8/8/01   5/2/03  
Bicillin CR and Bicillin CR 900/300 (Penicillin G Benzathine and Penicillin G Procaine Injectable Suspension, USP) and Bicillin LA (Penicillin G Benzathine Injectable Suspension),  King Pharmaceuticals, Inc. NDA 50-138/S-222, 50-138/S-223, 50-141/S-218 & 50-141/S-219 4/29/02 5/2/02    
Bicillin C-R and Bicillin C-R 900/300 Injection,  Wyeth-Ayerst Research NDA 50-138/S-219 3/1/02 3/5/02    
Bicillin L-A (penicillin G benzathine suspension) Injection,  Wyeth-Ayerst Research NDA 50-141/S-215 3/1/02 3/5/02    
BicNU (carmustine) Injection, Rx Bristol-Myers Squibb Company NDA 17-422/S-035 2/27/03 3/10/03    
Bisoprolol Fumarate Tablets, 5 and 10 mg, Rx Copley Pharmaceutical, Inc. ANDA: 75-644 6/26/01      
Bisoprolol Fumarate Tablets, 5 mg and 10 mg, Rx Eon Labs Manfacturing, Inc. ANDA 75-643 11/16/00 11/17/00    
Bisoprolol Fumarate Tablets, 5 mg and 10 mg, Rx Mutual Pharmaceutical Co., Inc. ANDA 75-474 10/25/02      
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx Mylan Pharmaceuticals, Inc. ANDA: 75-768 9/25/00 11/7/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx Teva Pharmaceuticals ANDA: 75-686 1/19/01 3/5/01    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx Purepac Pharmaceutical Co. ANDA: 75-672 9/25/00 11/7/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx, (Tentatively Approved: 5/11/2000) Purepac Pharmaceutical Co. ANDA: 75-672 5/11/00 5/22/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Rx Apothecon, Inc. ANDA 75-642 12/27/00 3/5/01    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Rx Zenith Goldline Pharmaceuticals, Inc. ANDA 75-632 9/27/00 11/7/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Rx Eon Labs Manfacturing, Inc. ANDA 75-579 9/25/00 11/7/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Rx (tentatively Approved 3/2/00) Eon Labs Manfacturing, Inc. ANDA 75-579 3/2/00 3/7/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Rx Invamed, Inc. ANDA 75-527 9/25/00 11/6/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets,2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg.6.25 mg, Rx (tentatively Approved 3/31/00) Invamed, Inc. ANDA 75-527 3/31/00 4/4/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx Chelsea Laboratories, Inc. ANDA: 75-469 9/25/00 11/6/00    
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg, Rx, (Tentatively Approved: 4/10/2000) Chelsea Laboratories, Inc. ANDA: 75-469 4/10/00 4/13/00    
Blenoxane (bleomycin sulfate) Injection, USP, Rx Bristol-Myers Squibb Company NDA 50-443/S-035 3/21/03 3/26/03 3/26/03  
Bleomycin for Injection USP, 15 units base/vial & 30 units base/vial, Rx Bedford Laboratories ANDA 65-042 10/17/01 4/10/03    
Bleomycin for Injection USP, 15 units base/vial & 30 units base/vial, Rx Gensia Sicor Pharmaceuticals, Inc. ANDA 65-033 6/27/00 10/30/00    
Bleomycin for Injection USP, 15 units base/vial & 30 units base/vial, Rx Faulding Pharmaceutical Co. ANDA 65-031 3/10/00 3/15/00    
Blocadren (Timolol Maleate) Tablets,  Merck & Co., Inc. NDA 18-017/S-037 3/27/02 4/8/02   5/30/02
Blocadren (Timolol Maleate) Tablets, 5mg, 10mg & 20mg, Rx Merck & Co., Inc. NDA 18-017/S-036 2/25/03 3/10/03   7/5/03
Boniva (ibandronate sodium) Tablets, Rx Hoffmann-La Roche Inc. NDA 21-455 5/16/03 6/9/03 7/9/03 7/2/03
BranchAmin 4% (branch chained amino acid) Injection, Rx Baxter Healthcare Corporation NDA 18-684/S-020 4/24/03      
Bravelle (Urofollitropin) Injection Purified, Rx Ferring Pharmaceuticals, Inc. NDA 21-484 12/19/02 1/30/03 4/9/03 5/8/03
Bravelle (Urofollitropin) Injection Purified, Rx Ferring Pharmaceuticals, Inc. NDA 21-289 5/6/02 5/9/02   10/9/02
  Bravelle Indication:  Ovulation Induction
BreathTek UBT Meretek Diagnostics NDA 20586/S4 5/10/01 7/24/03 4/25/03  
Brevibloc Concentrate (Esmolol Hydrochloride), 10 mg/mL Ampuls, Rx Baxter  NDA 19-386/S24 8/18/03 8/26/03    
Brevibloc (Esmolol Hydrochloride) Injection, 10 mg/mL Vial, Rx Baxter Pharmaceutical Products Inc. NDA 19-386/S21 2/25/03 3/10/03   7/8/03
Brevibloc Premixed Injection (esmolol hydrochloride) and Brevibloc Double Strength Premixed Injection, Rx Baxter Healthcare Corporation NDA 19-386/S19 & S20 1/27/03 2/12/03    
Brevibloc (Esmolol Hydrochloride) Injection, 250 mg/mL Ampule & 10 mg/mL Vial, Rx Baxter Pharmaceutical Products Inc. NDA 19-386 1/19/00     6/4/01
Brevital Sodium (Methohexytal sodium for injection USP), Rx King Pharmaceuticals, Inc. NDA 11-559/S-033 3/14/03 4/1/03    
Brevital Sodium (Methohexytal sodium for injection USP), Rx Eli Lilly and Company NDA 11-559/S-032 7/13/01 10/10/02    
Brimonidine Tartrate Ophthalmic Solution, 0.2%, Rx Bausch & Lomb ANDA 76-260 5/28/03      
Brimonidine Tartrate Ophthalmic Solution, 0.2%, Rx Alcon ANDA 76-254 9/16/03      
Brimonidine Tartrate Ophthalmic Solution, 0.2%, Rx Tentatively Approved Alcon Universal, Ltd. ANDA 76-254 5/29/03      
Bromocriptine Mesylate Capsules USP, 5 mg (base) Lek USA, Inc. ANDA 75-100 12/10/98 12/10/98   8/24/01
BSS (balanced salt solution) Sterile Irrigating Solution, Rx Alcon Laboratories, Inc. NDA 20-742/S-004 4/15/03      
BSS Plus (balanced salt solution enriched w/bicarbonate dextrose & glutathione) Sterile Irrigating Solution, Rx Alcon Laboratories, Inc. NDA 18-469/S36 & S37 4/15/03 7/28/03    
Bumex (bumetanide) Tablets & Bumex (bumetanide) Injection, 0.25, 1 and 2 mg  & 0.25 mg/mL, respectively, Rx Hoffmann-La Roche Inc. NDA 18-225/S-018 & 019 & 18-226/S-024 & 025 10/29/02 11/19/02   3/7/03
Bumex (bumetanide) Tablets, 0.25, 1 and 2 mg, Rx Hoffmann-La Roche Inc. NDA 18-225/S22 5/13/03 7/9/03    
Bupivacaine HCI Injection USP, 0.25%, 0.50% & 0.75%, Rx International Medication Systems, Limited ANDA 76-012 1/9/02      
Buprenex (buprenorphine hydrochloride) Injectable,  Reckitt Benckiser Pharmaceuticals, Inc. NDA 18-401/S-015 6/10/03 7/8/03     
Buprenex (buprenorphine hydrochloride) Injectable,  Reckitt Benckiser Pharmaceuticals, Inc. NDA 18-401/S-014 2/11/02 3/8/02    
Bupropion Hydrochloride Extended-Release Tablets, 100 & 150mg, Rx Eon Labs ANDA 75-932/S1,S2 3/22/04 3/23/04    
Bupropion Hydrochloride Extended-Release Tablets, 100 mg, Rx Eon Labs ANDA 75-932 11/25/03      
Bupropion Hydrochloride Extended-Release Tablets, 100 and 150 mg, Rx Eon Labs Manufacturing, Inc. ANDA 75-932 1/24/02 4/10/03    
Bupropion Hydrochloride Extended-Release Tablets, 150mg, Rx Impax Laboratories ANDA 75-913/S1,S2,S3 3/22/04      
Bupropion Hydrochloride Extended-Release Tablets, 100mg (approved) and (150mg Tentatively Approved), Rx Impax Laboratories ANDA 75-913 1/28/04      
Bupropion Hydrochloride Tablets, 75 mg and 100 mg, Rx Eon Labs Manufacturing, Inc. ANDA 75-613 10/10/00 11/7/00   12/5/01
Bupropion Hydrochloride Tablets, 75 mg and 100 mg, Rx Invamed Inc. ANDA 75-584 2/7/00 2/11/00   6/7/01
Bupropion Hydrochloride Tablets, 75 mg and 100 mg, Rx Mylan Pharmaceuticals Inc. ANDA 75-491 4/17/00 4/24/00   8/6/03
BuSpar (Buspirone Hydrochloride) Capsules Bristol-Myers Squibb Co. NDA 21-190 12/20/00     3/11/04
BuSpar (Buspirone Hydrochloride) Tablets  Bristol-Myers Squibb Co. NDA 18-731/S39 & S45        
BuSpar (Buspirone Hydrochloride) Tablets  Bristol-Myers Squibb Co. NDA 18-731/S46 2/7/02 4/17/02    
BuSpar (Buspirone Hydrochloride) Tablets Bristol-Myers Squibb Co. NDA 18-731/S43 7/19/01 11/5/01 11/5/01 4/14/04
Buspirone Hydrochloride Tablets USP, 30 mg, Rx Mylan Technologies Inc. ANDA 76-008 6/28/01      
Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Rx Novopharm Limited ANDA 74-684 10/9/98 10/13/98    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg & 15 mg, Rx Second Tentative Approval 5/23/00 Novopharm Limited ANDA 74-684 5/23/00 5/31/00    
Buspirone Hydrochloride Tablets USP,5 mg and 10 mg, Rx
Tentatively Approved 12/22/1998 & 9/17/99		 ESI Lederle ANDA 75-011 12/22/98
9/17/99		 12/22/98
9/24/99		    
Buspirone Hydrochloride Tablets USP,5 mg and 10 mg, Rx
Second Tentative Approval 5/23/00		 ESI Lederle ANDA 75-011 5/23/00 5/31/00    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, 15 mg & 30 mg, Rx Teva Pharmaceuticals USA ANDA 75-022/S1 3/26/04      
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg & 15 mg, Rx Teva Pharmaceuticals USA ANDA 75-022 2/28/02      
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg & 15 mg, Rx
Tentatively Approved		 Teva Pharmaceuticals USA ANDA 75-022 8/3/01      
Buspirone Hydrochloride Tablets USP, 15 mg, Rx Egis Pharmaceuticals, Ltd. ANDA 75-119/S1 & S2 1/23/03      
Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Rx Egis Pharmaceuticals, Ltd. ANDA 75-119 3/14/02 4/9/03    
Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Rx Tentatively approved Aegis Pharmaceuticals, Inc. ANDA 75-119 7/27/00 10/31/00    
Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Rx, Tentatively approved 11/16/1998 Aegis Pharmaceuticals ANDA 75-119 11/16/98 11/16/98    
Buspirone Hydrochloride Tablets, 5 mg and 10 mg Chelsea Laboratories ANDA 75-195 4/30/98 5/8/98    
Buspirone Hydrochloride Tablets USP, 15 mg, Rx  Watson Laboratories, Inc. ANDA 74-253/S1 & S2 3/13/02 4/9/03    
Buspirone Hydrochloride Tablets USP, 5 mg and 10 mg, Rx ( 15 mg strengths remain
Tentatively Approved)		 Danbury Pharmacal, Inc. ANDA 74-253 3/28/01 3/30/01    
Buspirone Hydrochloride Tablets USP, 5 & 10 mg, Rx  Mylan Pharmaceuticals ANDA 75-272/S3 & S4 3/1/02 4/10/03    
Buspirone Hydrochloride Tablets USP, 15 mg, Rx ( 5 mg & 10 mg strengths remain
Tentatively Approved)		 Mylan Pharmaceuticals ANDA 75-272 3/28/01 3/30/01    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Rx
Tentatively Approved		 Mylan Pharmaceuticals ANDA 75-272 8/2/00 10/30/00    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Rx
Tentatively Approved 11/10/98		 Mylan Pharmaceuticals ANDA 75-272 11/10/98  11/16/98    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 and 15 mg, Rx Zenith Goldline Pharmaceuticals, Inc. ANDA 75-385 3/1/02 4/10/03    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Rx PharmEx Products, Inc. ANDA 75-388 5/9/02      
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Rx
Tentatively Approved		 Applied Analytical Industries, Inc. ANDA 75-388 7/26/00 10/30/00    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg, Rx
Tentatively Approved 2/15/00		 Applied Analytical Industries, Inc. ANDA 75-388 2/15/99 2/17/00    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 & 15 mg, Rx Geneva Pharmaceuticals, Inc. ANDA 75-413 3/19/02 4/10/03    
Buspirone Hydrochloride Tablets USP,5 mg, 10 mg, and 15 mg. Tentatively Approved 12/21/99 Geneva Pharmaceuticals, Inc. ANDA 75-413 12/21/99 12/23/99    
Buspirone Hydrochloride Tablets USP,5 mg, 10 mg, and 15 mg. Second Tentative Approval 5/23/00 Geneva Pharmaceuticals, Inc. ANDA 75-413 5/23/00 5/31/00    
Buspirone Hydrochloride Tablets USP, 5, 10, & 15 mg, Rx Par Pharmaceutical, Inc. ANDA 75-467/S4 & S5 2/28/02 4/10/03    
Buspirone Hydrochloride Tablets USP, 5, 7.5, 10 & 15 mg, Rx Par Pharmaceutical, Inc. ANDA 75-467 3/28/01 3/30/01   7/17/02
Buspirone Hydrochloride Tablets USP, 5 mg, 7.5 mg, 10 mg, and 15 mg. Tentatively Approved Par Pharmaceutical, Inc. ANDA 75-467 12/28/99 1/3/00    
Buspirone Hydrochloride Tablets USP, 5 mg, 7.5 mg, 10 mg, and 15 mg. Second Tentative Approval 5/23/00 Par Pharmaceutical, Inc. ANDA 75-467 5/23/00 5/31/00    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg., Rx   Torpharm ANDA 75-521 4/5/02 4/10/02    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg., Rx Tentative Approval  Torpharm ANDA 75-521 5/9/01 6/5/01    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg., Rx KV Pharmaceutical, Co. ANDA 75-572 2/27/02 4/10/03    
Buspirone Hydrochloride Tablets USP, 5 mg, 10 mg, and 15 mg. Tentative Approval 8/4/00 KV Pharmaceutical, Co. ANDA 75-572 8/4/00 11/7/00    
BUSULFEX (busulfan) Injection, Rx Orphan Medical, Inc. NDA 20-954/S5 11/13/02 11/22/02 11/14/02 7/8/03
BUSULFEX (busulfan) Injection, Rx Orphan Medical, Inc. NDA 20-954/S4 1/13/03 1/23/03 1/23/03  
BUSULFEX (busulfan) Injection, Rx Orphan Medical, Inc. NDA 20-954/S3 4/24/02 5/2/02   3/9/04
BUSULFEX (busulfan) Injection, Rx Orphan Medical, Inc. NDA 20-954/S1 12/23/02 1/29/03   3/9/04
BUSULFEX (busulfan) Injection, intravenous, Rx Orphan Medical, Inc. NDA 20-954 2/4/99 2/5/99 2/10/99