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Paragraph IV Patent Certifications
As of May 6, 2008

Below is a list of drug products for which an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification. This list includes the name of the drug product, dosage form, strength (subject of Paragraph IV certification), reference listed drug (RLD), and the date on which the first substantially complete generic drug application was submitted to the Agency (on a prospective basis beginning 3/2/04). The Agency will not disclose the identity of the applicant. This information will be updated twice a month and will be as current as the last update. This information should be used for reference only. The Agency will make every effort to ensure the accuracy of the information disclosed in this list. However, any discrepancies or disparities should be discussed with the Regulatory Support Branch at 301-827-5862, before making any decisions based on this information.

Any additions from the preceding list are marked with the New icon.

DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION
Abacavir Sulfate and Lamivudine Tablets 600 mg/300 mg Epzicom 9/27/2007
Acarbose Tablets 25 mg, 50 mg and 100 mg Precose 3/22/2005
Acetaminophen Extended-release Tablets 650 mg Tylenol  
Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/
65 mg		 Excedrin
(migraine)		  
Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet  
Acyclovir Sodium Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax  
Adenosine Injection 3 mg/mL, 20 mL and 30 mL vials Adenoscan 4/18/2005
Albuterol Sulfate Oral Syrup 2 mg(base)/
5 mL		 Ventolin  
Albuterol Sulfate Extended-release Tablets 4 mg and 8 mg Volmax  
Albuterol Sulfate Inhalation Solution 0.021% and 0.042% Accuneb 10/19/2005
Albuterol Sulfate/ Ipratropium Bromide Inhalation Solution 0.083%/ 0.017% Duoneb  
Alendronate Sodium Oral Solution 70 mg/75 mL Fosamax 9/7/2007
Alendronate Sodium Tablets 5 mg, 10 mg, 35 mg, 40 mg and 70 mg Fosamax  
Alendronate Sodium and Cholecalciferol Tablets 70 mg/2800 IU and 70 mg/5600 IU Fosamax Plus D 11/20/2007
Alfuzosin Hydrochloride Extended-release Tablets 10 mg Uroxatral 6/12/2007
Alprazolam Orally Disintegrating Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg Niravam 12/27/2005
Alprazolam Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg Xanax  
Almotriptan Malate Tablets 6.25 mg and 12.5 mg Axert 12/8/2005
Amifostine For Injection 500 mg/vial Ethyol 4/16/2004
Amlodipine Besylate Tablets 2.5 mg, 5 mg and 10 mg Norvasc  
Amlodipine Besylate and Atorvastatin Calcium Tablets Tablets 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 10 mg/10 mg, 10 mg/20 mg and 10 mg/80 mg Caduet 12/29/2006
Amlodipine Besylate and Benazepril Hydrochloride Capsules 2.5 mg/10 mg, 5 mg/10 mg, 5 mg/20 mg and 10 mg/20 mg Lotrel 6/9/2004
Amlodipine Besylate and Benazepril Hydrochloride Capsules 5 mg/40 mg and 10 mg/40 mg Lotrel 11/17/2006
Amlodipine Besylate and Olmesartan Medoxomil Tablets 5 mg/20 mg and 10 mg/40 mg Azor 2/11/2008
Amlodipine Besylate and Valsartan Tablets 5 mg/160 mg Exforge 10/22/2007
Amlodipine Besylate and Valsartan Tablets 5 mg/320 mg Exforge 11/26/2007
Amlodipine Besylate and Valsartan Tablets 10 mg/160 mg Exforge 10/1/2007
Amlodipine Besylate and Valsartan Tablets 10 mg/320 mg Exforge 11/9/2007
Argatroban Injection 100 mg/mL, 2.5 mL vials Argatroban 9/24/2007
Aripiprazole Oral Solution 1 mg/mL Abilify 12/20/2007
Aripiprazole Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg Abilify 11/15/2006
Aripiprazole Orally Disintegrating Tablets 10 mg, 15 mg, 20 mg and 30 mg Abilify 11/15/2006
Aspirin and Dipyridamole Extended-release Capsules 25 mg and 200 mg Aggrenox 2/1/2007
Atenolol Tablets 25 mg, 50 mg and 100 mg Tenormin  
Atenolol/ Chlorthalidone Tablets 50 mg/25 mg and 100 mg/25 mg Tenoretic  
Atomoxetine Hydrochloride Capsules 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg Strattera 5/29/2007
Atorvastatin Calcium Tablets 10 mg, 20 mg, 40 mg and 80 mg Lipitor  
Azelastine Hydrochloride Nasal Spray 0.125 mg base/spray Astelin 11/14/2005
Azelastine Hydrochloride Ophthalmic Solution 0.05% Optivar 12/13/2006
Betamethasone Valerate Foam 0.12% Luxiq 8/10/2007
Betaxolol Ophthalmic Solution 0.5%(base) Betoptic  
Brimonidine Tartrate Ophthalmic Solution 0.1% Alphagan P 12/20/2006
Brimonidine Tartrate Ophthalmic Solution 0.15% Alphagan P 11/03/2006
Brimonidine Tartrate Ophthalmic Solution 0.2% Alphagan  
Budesonide Enteric Coated Capsules 3 mg Entocort EC 2/1/2008
Budesonide Nasal Spray 0.032 mg (32 mcg)/spray Rhinocort 5/14/2007
Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL Pulmicort Respules 9/15/2005
Bupropion Hydrochloride Extended-release Tablets 100 mg, 150 mg and 200 mg Wellbutrin SR  
Bupropion Hydrochloride Extended-release Tablets 150 mg Zyban  
Bupropion Hydrochloride Extended-release Tablets 150 mg and 300 mg Wellbutrin XL 9/21/2004
Bupropion Hydrochloride Tablets 75 mg and 100 mg Wellbutrin  
Buspirone Hydrochloride Tablets 5 mg, 7.5 mg, 10 mg, 15 mg and 30 mg Buspar  
Butorphanol Tartrate Nasal Spray 10 mg/mL Stadol NS  
Calcipotriene Topical Solution 0.005% Dovonex 5/19/2006
Calcitonin-Salmon Nasal Spray 200 IU/spray Miacalcin  
Calcitonin-Salmon (Recombinant) Nasal Spray 200 IU/spray Fortical 3/29/2006
Calcitriol Injection 1 mcg/mL and 2 mcg/mL, 1 mL vials Calcijex  
Calcium Acetate Capsules EQ 169 mg calcium PhosLo 5/31/2005
Calcium Carbonate/ Famotadine/ Magnesium Hydroxide Chewable Tablets 800 mg/ 10 mg/ 165 mg (OTC) Pepcid Complete 11/1/2004
Candesartan Cilexetil Tablets 4 mg, 8 mg, 16 mg and 32 mg Atacand 12/22/2006
Captopril Tablets 12.5 mg, 25 mg, 50 mg, and 100 mg Capoten  
Carbamazepine Extended-release Capsules 100 mg and 200 mg Carbatrol 2/2/2006
Carbamazepine Extended-release Capsules 200 mg and 300 mg Equetro 8/21/2007
Carbamazepine Extended-release Capsules 300 mg Carbatrol  
Carbamazepine Extended-release Tablets 100 mg Tegretol-XR 12/30/2005
Carbamazepine Extended-release Tablets 200 mg and 400 mg Tegretol-XR  
Carbidopa/ Levodopa Extended-release Tablets 25 mg/100 mg and 50 mg/200 mg Sinemet CR  
Carbidopa, Levodopa and Entacapone Tablets 25/100/200 mg and 37.5/150/200 mg Stalevo 100 and Stalevo 150 6/29/2007
Carboplatin For Injection 50 mg/vial, 150 mg/vial and 450 mg/vial Paraplatin  
Carboplatin Injection 50 mg/vial, 150 mg/vial and 450 mg/vial Paraplatin  
Carisoprodol/ Aspirin Tablets 200 mg/ 325 mg Soma Compound  
Carisoprodol/ Aspirin/ Codeine Tablets 200 mg/ 325 mg/ 16 mg Soma Compound with Codeine  
Carvedilol Tablets 3.125 mg, 6.25 mg, 12.5 mg and 25 mg Coreg  
Carvedilol Phosphate Extended-release Capsules 40 mg Coreg CR 12/21/2007
Carvedilol Phosphate Extended-release Capsules 80 mg Coreg CR 11/19/2007
Celecoxib Capsules 100 mg, 200 mg and 400 mg Celebrex  
Cetirizine Hydrochloride Syrup 5 mg/5 mL Zyrtec 3/19/2007
Cetirizine Hydrochloride and Pseudoephedrine Extended-release Tablets 5 mg/120 mg Zyrtec-D 6/2/2004
Cetirizine Hydrochloride Chewable Tablets 5 mg and 10 mg Zyrtec 3/25/2005
Chlorhexidine Gluconate Scrub brush/sponge 4% Hibiclens  
Chlorpheniramine Polistirex and Hydrocodone Polistirex Extended-release Capsules 8 mg/10 mg and 4 mg/5 mg Tussionex 9/10/2004
Ciclopirox Gel 0.77% Loprox 5/10/2006
Ciprofloxacin Hydrochloride Tablets 100 mg, 250 mg, 500 mg and 750 mg Cipro  
Cisplatin Injection 1 mg/mL, 10 mL, 50 mL, 100 mL and 200 mL vials Platinol-AQ  
Cisplatin For Injection 10 mg/vial and 50 mg/vial Platinol  
Clobetasol Propionate Topical Foam 0.05% Olux 6/27/2005
Clobetasol Propionate Lotion 0.05% Clobex 3/27/2006
Clonidine Hydrochloride Transdermal System 0.1 mg/day, 0.2 mg/day, and 0.3 mg/day Catapres-TTS  
Clopidogrel Bisulfate Tablets 75 mg Plavix  
Colestipol Hydrochloride Tablets 1 g Colestid 8/23/2005
Conjugated Estrogens Tablets 0.3 mg and 0.625 mg Premarin  
Cyclobenzaprine Hydrochloride Tablets 10 mg Flexeril  
Cyclophosphamide For Injection 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial and 2 g/vial Cytoxan  
Desloratadine Tablets 5 mg Clarinex 6/21/2006
Desloratadine Orally Disintegrating Tablets 2.5 mg and 5 mg Clarinex 6/21/2006
Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets 2.5 mg/120 mg Clarinex-D 24 Hour 6/1/2007
Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets 5 mg/240 mg Clarinex-D 24 Hour 6/21/2006
Desmopressin Acetate Injection 4 mcg/mL, 1 mL and 10 mL vials DDAVP  
Desmopressin Acetate Nasal Spray 0.01% DDAVP  
Desmopressin Acetate Tablets 0.1 mg and 0.2 mg DDAVP  
Desogestrel; Ethinyl Estradiol Tablets Tablets 0.15mg/  0.02 mg and 0.01 mg Mircette  
Dexmethylphenidate Hydrochloride Tablets 2.5 mg Focalin 7/27/2004
Dexmethylphenidate Hydrochloride Tablets 5 mg and 10 mg Focalin 5/27/2004
Dexmethylphenidate Hydrochloride Extended-release Capsules 15 mg Focalin XR 5/14/2007
Dexmethylphenidate Hydrochloride Extended-release Capsules 5 mg, 10 mg and 20 mg Focalin XR 3/30/2007
Dexrazoxane For Injection 250 mg/vial Zinecard  
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate Extended-release Capsules 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg Adderall XR  
Dextroamphetamine saccharate; Amphetamine aspartate; Dextroamphetamine Sulfate; Amphetamine Sulfate Tablets 7.5 mg, 12.5 mg and 15 mg Adderall  
Diazepam Tablets 2 mg, 5 mg and 10 mg Valium  
Diazepam Rectal Gel 2.5 mg/0.5 mL, 5 mg/mL, 10 mg/2 mL, 15 mg/3 mL and 20 mg/4 mL Diastat 3/23/2004
Didanosine Delayed-release Capsules 200 mg, 250 mg and 400 mg Videx EC 6/1/2004
Diltiazem Hydrochloride Extended-release Capsules 60 mg, 90 mg and 120 mg Cardizem SR  
Diltiazem Hydrochloride Extended-release Capsules 120 mg, 180 mg and 240 mg Dilacor XR  
Diltiazem Hydrochloride Extended-release Capsules 120 mg, 180 mg, 240 mg and 300 mg Cardizem CD  
Diltiazem Hydrochloride Extended-release Capsules 120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg Tiazac  
Diltiazem Hydrochloride Extended-release Tablets 120 mg, 180 mg, 240 mg, 300 mg and 360 mg Cardizem LA 8/30/2005
Diltiazem Hydrochloride Extended-release Tablets 420 mg Cardizem LA 4/25/2005
Divalproex Sodium Delayed-release Tablets 125 mg, 250 mg and 500 mg Depakote  
Divalproex Sodium Extended-release Tablets 250 mg Depakote ER 5/3/2004
Divalproex Sodium Extended-release Tablets 500 mg Depakote ER 2/8/2005
Donepezil Hydrochloride Tablets 5 mg and 10 mg Aricept  
Dorzolamide Hydrochloride Ophthalmic Solution 2% Trusopt 10/11/2005
Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution 2%/0.5% Cosopt 10/11/2005
Doxazosin Mesylate Tablets 1 mg, 2 mg, 4 mg and 8 mg Cardura  
Doxercalciferol Injection 2 mcg/mL, 2 mL ampules Hectorol 10/15/2007
Drospirenone and Estradiol Tablets 0.5 mg/1 mg Angeliq 12/26/2007
Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.02 mg Yaz 9/29/2006
Drospirenone and Ethinyl Estradiol Tablets 3 mg/0.03 mg Yasmin 1/7/2005
Dutasteride Capsules 0.5 mg Avodart 10/29/2007
Enalapril Maleate Tablets 2.5 mg, 5 mg, 10 mg and 20 mg Vasotec  
Enoxaparin Sodium Injection 100 mg/mL, 0.3 mL, 0.4 mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes Lovenox  
Enoxaparin Sodium Injection 150 mg/mL, 0.6 mL, 0.8 mL and 1 mL prefilled syringes Lovenox  
Enoxaparin Sodium Injection 100 mg/mL, 3 mL vials Lovenox 12/7/2006
Entacapone Tablets 200 mg Comtan 4/11/2007
Eplerenone Tablets 25 mg and 50 mg Inspra 9/27/2006
Escitalopram Oxalate Capsules 5 mg Lexapro 8/17/2005
Escitalopram Oxalate Capsules 10 mg and 20 mg Lexapro 3/30/2005
Escitalopram Oxalate Tablets 5 mg, 10 mg and 20 mg Lexapro  
Esmolol Hydrochloride Injection 10 mg/mL, 10 mL vial Brevibloc  
Esomeprazole Magnesium Delayed-release Capsules 20 mg and 40 mg Nexium 8/5/2005
Estradiol Transdermal System 0.0375 mg/day and 0.06 mg/day Climara  
Estradiol Transdermal System 0.05 mg/day and 0.1 mg/day Climara 9/12/2005
Estradiol; Estradiol and Norgestimate Tablets 1 mg; 1 mg and 0.09 mg Prefest  
Etodolac Extended-release Tablets 400 mg, 500 mg and 600 mg Lodine XL  
Ezetimibe Tablets 10 mg Zetia 10/25/2006
Famciclovir Tablets 125 mg, 250 mg and
500 mg		 Famvir 12/28/2004
Famotidine Injection 10 mg/mL, 2 mL vials; unpreserved Pepcid  
Famotidine Injection 10 mg/mL, 4 mL and 20 mL vials; preserved Pepcid  
Famotidine Injection 10 mg/mL, 50 mL vial, pharmacy bulk package; unpreserved Pepcid  
Famotidine Tablets 10 mg (OTC) Pepcid AC  
Famotidine Tablets 20 mg and 40 mg Pepcid  
Famotidine Tablets (Chewable) 10 mg (OTC) Pepcid AC (chewable)  
Felodipine Extended-release Tablets 2.5 mg, 5 mg and 10 mg Plendil ER  
Fenofibrate Capsules 67 mg, 134 mg and 200 mg Tricor  
Fenofibrate Tablets 54 mg, 107 mg and 160 mg Tricor  
Fenofibrate Tablets 145 mg Tricor 10/19/2007
Fentanyl Transdermal Extended-release Film 0.6 mg/24 hr, 1.2 mg/ 24 hr, 1.8 mg/ 24 hr and 2.4 mg/ 24 hr Duragesic  
Fentanyl Citrate Buccal Tablets 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg Fentora 11/13/2007
Fentanyl Citrate Lozenges 0.2 mg Actiq 10/29/2004
Fentanyl Citrate Lozenges 0.4 mg Actiq 10/6/2004
Fentanyl Citrate Lozenges 0.6 mg Actiq 12/20/2004
Fentanyl Citrate Lozenges 0.8 mg, 1.2 mg and 1.6 mg Actiq 11/22/2004
Fexofenadine Hydrochloride Capsules 60 mg Allegra  
Fexofenadine Hydrochloride Tablets 30 mg, 60 mg and 180 mg Allegra  
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets 60 mg/120 mg Allegra-D  
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release Tablets 180 mg/240 mg Allegra-D 24 Hour 6/6/2007
Finasteride Tablets 1 mg Propecia  
Finasteride Tablets 5 mg Proscar  
Flecainide Acetate Tablets 50 mg, 100 mg and 150 mg Tambocor  
Fluconazole For Oral Suspension 50 mg/5 mL and 200 mg/5 mL Diflucan for Oral Suspension  
Fluconazole Tablets 50 mg, 100 mg, 150 mg and 200 mg Diflucan  
Flunisolide Nasal Solution 0.025% Nasalide  
Fluocinonide Cream 0.1% Vanos 1/31/2008
Fluocinonide Ointment 0.05% Lidex  
Fluoxetine Hydrochloride Tablets 10 mg and 20 mg Prozac  
Fluoxetine Hydrochloride Capsules 10 mg, 20 mg and 40 mg Prozac  
Fluoxetine Hydrochloride Delayed-release Capsules 90 mg Prozac Weekly  
Fluoxetine Hydrochloride Oral Solution 20 mg (base)/5 mL Prozac  
Fluoxetine Hydrochloride Capsules 10 mg and 20 mg Sarafem  
Flutamide Capsules 125 mg Eulexin  
Fluvastatin Sodium Extended-release Tablets 80 mg Lescol XL 3/15/2007
Fosinopril Sodium Tablets 10 mg, 20 mg and 40 mg Monopril  
Fosinopril Sodium and Hydrochlorothiazide Tablets 10 mg/12.5 mg and 20 mg/12.5 mg Monopril HCT  
Gabapentin Capsules 100 mg, 300 mg and 400 mg Neurontin  
Gabapentin Oral Solution 250 mg/5 mL Neurontin  
Gabapentin Tablets 100 mg, 300 mg and 400 mg Neurontin  
Gabapentin Tablets 600 mg and 800 mg Neurontin  
Galantamine Hydrobromide Extended-release Capsules 8 mg Razadyne ER 3/2/2006
Galantamine Hydrobromide Extended-release Capsules 16 mg and 24 mg Razadyne ER 3/11/2006
Galantamine Hydrobromide Tablets 4 mg, 8 mg and 12 mg Razadyne 2/28/2005
Ganciclovir Sodium Capsules 250 mg and 500 mg Cytovene  
Gatifloxacin Injection 10 mg/mL, 20 mL and 40 mL vials Tequin 11/24/2004
Gatifloxacin Ophthalmic Solution 0.3 % Zymar 7/19/2007
Gatifloxacin Tablets 200 mg and 400 mg Tequin  
Gatifloxacin in Dextrose 5% in Plastic Container Injection 2 mg/mL, 100 mL and 200 mL containers (plastic) Tequin 12/13/2004
Gemcitabine For Injection 200 mg/vial Gemzar 11/1/2005
Gemcitabine For Injection 1g/vial Gemzar 11/14/2005
Gemcitabine For Injection 2 g/vial Gemzar 8/24/2007
Glimepiride and Rosiglitazone Maleate Tablets 1 mg/4 mg, 2 mg/4 mg and 4 mg/4 mg Avandaryl 12/22/2006
Glipizide Extended-release Tablets 2.5 mg, 5 mg and 10 mg Glucotrol XL  
Glyburide Tablets 1.5 mg, 3 mg, 4.5 mg and 6 mg Glynase  
Glyburide/
Metformin Hydrochloride		 Tablets 1.25mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg Glucovance  
Granisetron Hydrochloride Injection 0.1 mg/mL, 1 mL single dose vial Kytril 3/8/2007
Granisetron Hydrochloride Injection 1 mg/mL, 1 mL vials Kytril 6/1/2004
Granisetron Hydrochloride Injection 1 mg/mL, 4 mL multi-dose vials Kytril 7/19/2004
Guaifenesin * Extended-release Tablets 600 mg and 1.2 gm Mucinex 6/9/2006
Hydrocodone Bitartrate and Ibuprofen Tablets 2.5 mg/200 mg Vicoprofen 2/24/2006
Hydrocodone Bitartrate and Ibuprofen Tablets 5 mg/200 mg Vicoprofen 5/27/2005
Hydrocodone Bitartrate and Ibuprofen Tablets 7.5 mg/200 mg Vicoprofen  
Hydrocodone Bitartrate and Ibuprofen Tablets 10 mg/200 mg Vicoprofen  
Ibandronate Sodium Injection 1 mg/mL, 3 mL Vial Boniva 8/31/2007
Ibandronate Sodium Tablets 2.5 mg and 150 mg Boniva 5/16/2007
Ibuprofen Oral Drops 40 mg/mL Children's Motrin Drops  
Ibuprofen Oral Suspension 50 mg/1.25 mL Concentrated Motrin Infant Drops 6/29/2007
Ibuprofen Oral Suspension 100 mg/5 mL (Rx) Motrin  
Ibuprofen Oral Suspension 100 mg/5 mL (OTC) Children's Motrin  
Ibuprofen Chewable Tablets 50 mg and 100 mg Children's Motrin, Junior Strength Motrin  
Ibuprofen Potassium and Pseudoephedrine Hydrochloride Capsules 200 mg/30 mg Advil Cold and Sinus 12/27/2004
Ibuprofen and Pseudoephedrine Hydrochloride Oral Suspension 100 mg/ 15 mg per 5 mL Children's Motrin Cold  
Ibuprofen and Pseudoephedrine Hydrochloride Tablets 200 mg/30 mg Advil Cold and Sinus  
Ifosfamide For Injection 1 g/vial and 3 g/vial Ifex  
Ifosfamide Injection 50 mg/mL, 20 mL vials and 60 mL vials Ifex  
Ifosfamide/ Mesna For Injection/ Injection Kit 1 g/vial; 100 mg/mL, 10 mL vials and 3 g/vial; 100 mg/mL, 10 mL vials Ifex/ Mesnex Kit  
Ifosfamide/ Mesna Injection/ Injection Kit 50 mg/mL, 20 mL and 60 mL vials; 100 mg/mL, 10 mL vial Ifex/ Mesnex Kit  
Imatinib Mesylate Tablets 100 mg and 400 mg Gleevec 3/12/2007
Imiquimod Cream 5% Aldara 10/17/2006
Indomethacin Extended-release Capsules 75 mg Indocin SR  
Irbesartan Tablets 75 mg, 150 mg and 300 mg Avapro 5/25/2004
Irbesartan and Hydrochlorothiazide Tablets 150 mg/12.5 mg and 300 mg/12.5 mg Avalide 11/10/2004
Irbesartan and Hydrochlorothiazide Tablets 300 mg/25 mg Avalide 6/6/2006
Irinotecan Hydrochloride Injection 20 mg/mL, 2 mL and 5 mL vials Camptosar 7/26/2004
Itraconazole Capsules 100 mg Sporanox  
Ketoprofen Capsules 25 mg, 50 mg and 75 mg Orudis  
Ketorolac Tromethamine Injection 15 mg/mL and 30 mg/mL Toradol  
Ketorolac Tromethamine Ophthalmic Solution 0.5% Acular  
Ketorolac Tromethamine Ophthalmic Solution 0.4% Acular LS 1/28/2005
Ketorolac Tromethamine Tablets 10 mg Toradol  
Ketotifen Fumarate Ophthalmic Solution 0.025% Zaditor 12/23/2004
Lactulose Oral Syrup 10 g/15 mL Cephulac  
Lamivudine Tablets 100 mg Epivir-HBV 10/31/2007
Lamivudine Tablets 150 mg and 300 mg Epivir 10/16/2007
Lamivudine and Zidovudine Tablets 150 mg/300 mg Combivir 6/26/2007
Lactulose Oral Syrup 10 g/15 mL Chronulac  
Lamotrigine Tablets 25 mg, 100 mg, 150 mg and 200 mg Lamictal  
Lamotrigine Chewable Tablets 2 mg, 5 mg and 25 mg Lamictal CD  
Lansoprazole Delayed-release Pellets/Capsules 15 mg and 30 mg Prevacid 12/05/2005
Lansoprazole Delayed-release Orally Disintegrating Tablets 15 mg and 30 mg Prevacid 12/27/2006
Latanoprost Ophthalmic Solution 0.005% Xalatan  
Letrozole Tablets 2.5 mg Femara 3/2/2006
Leuprolide Acetate Injection (depot) 7.5 mg/vial Lupron Depot  
Levalbuterol Hydrochloride Inhalation Solution 0.0103%, 0.021% and 0.042% Xopenex 6/20/2005
Levalbuterol Hydrochloride Inhalation Solution 0.25%
Xopenex 5/23/2006
Levetiracetam Tablets 250 mg, 500 mg and 750 mg Keppra  
Levetiracetam Tablets 1000 mg Keppra 1/24/2007
Levocetirizine Dihydrochloride Tablets 5 mg Xyzal 12/17/2007
Levofloxacin Injection 5 mg/mL; 50 mL, 100 mL and 150 mL vials Levaquin in Dextrose 5% in Plastic Container  
Levofloxacin Injection 25 mg/mL Levaquin  
Levofloxacin Ophthalmic Solution 0.5% Quixin  
Levofloxacin Tablets 250 mg, 500 mg and 750 mg Levaquin  
Levonorgestrel and Ethinyl Estradiol Tablets 0.09 mg/0.02 mg Lybrel 10/5/2007
Levonorgestrel and Ethinyl Estradiol Tablets 0.15 mg/0.03 mg Seasonale 3/29/2004
Levothyroxine Sodium Tablets 0.025 mg, 0.05 mg, 0.075 mg, 0.088 mg, 0.1 mg, 0.112 mg, 0.125 mg, 0.150 mg, 0.175 mg, 0.2 mg and 0.3 mg Levoxyl  
Linezolid Tablets 600 mg Zyvox 12/21/2005
Loperamide Hydrochloride and Simethicone Chewable Tablets 2 mg/125 mg Imodium Advanced  
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg Imodium Advanced 12/29/2004
Loratadine Syrup 1 mg/mL Claritin  
Loratadine Tablets 10 mg Claritin  
Loratadine Orally Disintegrating Tablets 10 mg Claritin RediTabs  
Loratadine/ Pseudoephedrine Extended-release Tablets 5 mg/120 mg Claritin D-12 hour  
Loratadine/ Pseudoephedrine Extended-release Tablets 10 mg/240 mg Claritin D-24 hour  
Losartan Potassium Tablets 25 mg, 50 mg, and 100 mg Cozaar  
Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg
and 100 mg/25 mg		 Hyzaar 5/24/2004
Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg Hyzaar 4/4/2006
Mefloquine Hydrochloride Tablets 250 mg Lariam  
Megestrol Acetate Oral Suspension 40 mg/mL Megace  
Memantine Hydrochloride Tablets 5 mg and 10 mg Namenda 10/16/2007
Mesalamine Delayed-release Tablets 400 mg Asacol 6/22/2007
Metaxalone Tablets 400 mg Skelaxin  
Metaxalone Tablets 800 mg Skelaxin 11/4/2004
Metformin Hydrochloride Extended-release Tablets 500 mg Glucophage XR  
Metformin Hydrochloride Extended-release Tablets 750 mg Glucophage XR  
Methylphenidate Hydrochloride Extended-release Capsules 10 mg Ritalin LA 5/21/2007
Methylphenidate Hydrochloride Extended-release Capsules 10 mg, 20 mg and 30 mg Metadate CD 5/13/2005
Methylphenidate Hydrochloride Extended-release Capsules 20 mg, 30 mg and 40 mg Ritalin LA 8/21/06
Methylphenidate Hydrochloride Extended-release Capsules 40 mg Metadate CD 3/15/2007
Methylphenidate Hydrochloride Extended-release Tablets 18 mg, 27 mg, 36 mg and 54 mg Concerta 7/19/2005
Metoclopramide Hydrochloride Injection 5 mg/mL, 2 mL, 10 mL, 20 mL and 30 mL vials Reglan  
Metoprolol Succinate Extended-release Tablets 25 mg, 50 mg,
100 mg and
200 mg		 Toprol XL  
Metronidazole Vaginal Gel 0.75% MetroGel-Vaginal 9/2/2004
Miconazole Nitrate Vaginal Cream and Suppository 2% and 1.2 g Monistat 1 Combination Pack 12/5/2007
Mirtazapine Tablets 7.5 mg, 15 mg, 30 mg, and 45 mg Remeron  
Mirtazapine Orally Disintegrating Tablets 15 mg, 30 mg and 45 mg Remeron SolTab  
Modafinil Tablets 100 mg and 200 mg Provigil  
Moexipril Hydrochloride Tablets 7.5 mg and 15 mg Univasc  
Moexipril Hydrochloride and Hydrochlorothiazide Tablets 7.5mg/12.5mg
15 mg/25 mg and 15 mg/12.5 mg		 Uniretic