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Paragraph IV Patent Certifications
As of November 2, 2004


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 on a bi-monthly basis 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 will be highlighted in red (Note, new additions are not always received).

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DRUG NAME DOSAGE FORM STRENGTH RLD DATE OF SUBMISSION
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  
Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin  
Albuterol Sulfate Extended-release Tablets 4 mg and 8 mg Volmax  
Albuterol Sulfate/ Ipratropium Bromide Inhalation Solution 0.083%/ 0.017% Duoneb  
Alendronate Sodium Tablets 5 mg, 10 mg, 
35 mg, 40 mg and 70 mg
Fosamax  
Alprazolam Tablets 0.25 mg, 0.5 mg, 1 mg and
2 mg
Xanax  
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 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
Atenolol Tablets 25 mg, 50 mg and 100 mg Tenormin  
Atenolol/ Chlorthalidone Tablets 50 mg/25 mg and 100 mg/25 mg Tenoretic  
Atorvastatin Calcium Tablets 10 mg, 20 mg, 
40 mg and 80 mg
Lipitor  
Betaxolol Ophthalmic Solution 0.5%(base) Betoptic  
Brimonidine Tartrate Ophthalmic Solution 0.2% Alphagan
Bupropion Hydrochloride Extended-release Tablets 150 mg Zyban  
Bupropion Hydrochloride Extended-release Tablets 100 mg, 150 mg and 200 mg Wellbutrin SR  
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  
Calcitonin-Salmon Nasal Spray 200 IU/spray

 

Miacalcin
Calcitriol Injection 1 mcg/mL and 
2 mcg/mL,  1 mL vials
Calcijex  
Captopril Tablets 12.5 mg,  25 mg, 
50 mg, and 100
mg
Capoten  
Carbamazepine Extended-release Tablets 200 mg and 400 mg Tegretol XR  
Carbamazepine  Extended-release Capsules 300 mg Carbatrol  
Carbidopa/ Levodopa Extended-release Tablets 25 mg/100 mg and 50 mg/200 mg Sinemet CR  
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  
Celecoxib Capsules 100 mg, 200 mg and 400 mg Celebrex  
Cetirizine Hydrochloride and Pseudoephedrine Extended-release Tablets 5 mg/120 mg Zytrec-D 6/2/2004
Chlorhexidine Gluconate Scrub brush/sponge 4% Hibiclens
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-release Capsules 8 mg/10 mg and
4 mg/5 mg
Tussionex 9/10/2004
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  
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
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  
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 5 mg and 10 mg Focalin 5/27/2004
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 120 mg, 180 mg and 240 mg Dilacor XR  
Diltiazem Hydrochloride Extended-release Capsules 120 mg, 180 mg, 240 mg, 300 mg, 360 mg and 420 mg Tiazac  
Diltiazem Hydrochloride Extended-release Capsules 120 mg, 180 mg, 240 mg and 300 mg Cardizem CD  
Diltiazem Hydrochloride Extended-release Capsules 60 mg, 90 mg and 120 mg Cardizem SR  
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
Donepezil Hydrochloride Tablets 5 mg and 10 mg Aricept  
Doxazosin Mesylate Tablets 1 mg, 2 mg, 4 mg and 8 mg Cardura  
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

150 mg/mL, 0.6 mL, 0.8 mL and    1 mL prefilled syringes

Lovenox  
Escitalopram Oxalate Tablets 5 mg, 10 mg and 20 mg Lexapro  
Esmolol Hydrochloride Injection 10 mg/mL, 10 mL vial Brevibloc  
Estradiol Transdermal System 0.05 mg/day and  0.1 mg/day Climara  
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  
Famotidine Tablets 10 mg (OTC) Pepcid AC  
Famotidine Tablets 20 mg and 40 mg 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 Injection 10 mg/mL, 2 mL vials; unpreserved 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  
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  
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  
Finasteride Tablets 5 mg Proscar
Finasteride Tablets 1 mg Propecia
Flecainide Acetate Tablets 50 mg, 100 mg and 150 mg Tambocor  
Fluconazole Tablets 50 mg, 100 mg, 150 mg and 200 mg Diflucan  
Fluconazole For Oral Suspension 50 mg/5 mL and 200 mg/5 mL Diflucan for Oral Suspension  
Flunisolide Nasal Solution 0.025% Nasalide
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 Capsule 125 mg Eulexin
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 Tablets 600 mg and 800 mg Neurontin  
Gabapentin Oral Solution 250 mg/5 mL Neurontin  
Gatifloxacin Tablets 200 mg and
400 mg
Tequin  
Ganciclovir Sodium Capsules 250 mg and 500 mg Cytovene  
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

 

Granisetron Hydrochloride

 

Granisetron Hydrochloride

Injection

 

Injection

 

Injection

1 mg/mL, 1 mL vials
 

1 mg/mL, 4 mL multi-dose vials

1 mg/mL, 1 mL vials
(preserved)

 

Kytril

 

Kytril

 

Kytril

6/1/2004

 

7/19/2004

 

8/20/2004

Hydrocodone Bitartrate and Ibuprofen Tablets 7.5 mg/200 mg Vicoprofen  
Ibuprofen Chewable Tablets 50 mg and 100 mg Children's Motrin, Junior Strength Motrin  
Ibuprofen Oral Suspension 100 mg/5 mL (Rx) Motrin  
Ibuprofen Oral Suspension 100 mg/5 mL (OTC) Children's Motrin  
Ibuprofen Oral Drops 40 mg/mL Children's Motrin Drops  
Ibuprofen and Pseudoephedrine Hydrochloride Tablets 200 mg/30 mg Advil Cold and Sinus  
Ibuprofen and Pseudoephedrine Hydrochloride Oral Suspension 100 mg/ 15 mg     per 5 mL

 

Children's Motrin Cold
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  
Indomethacin Extended-release Capsules 75 mg Indocin SR  
Irbesartan Tablets 75 mg, 150 mg and 300 mg Avapro 5/25/2004
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 Tablets 10 mg Toradol
Lactulose Oral Syrup 10 g/15 mL Cephulac
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  
Latanoprost Ophthalmic Solution 0.005% Xalatan
Leuprolide Acetate Injection (depot) 7.5 mg/vial Lupron Depot
Levetiracetam Tablets 250 mg, 500 mg and 750 mg Keppra
Levofloxacin Tablets 250 mg, 500 mg and 750 mg Levaquin  
Levofloxacin Injection 25 mg/mL Levaquin
Levofloxacin Injection 5 mg/mL; 50 mL,   100 mL and 150 mL vials Levaquin in Dextrose 5% in Plastic Container  
Levofloxacin Ophthalmic Solution 0.5% Quixin  
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  
Loperamide HCl and
Simethicone
Tablets 2 mg/125 mg Imodium Advanced  
Loratadine Tablets 10 mg Claritin
Loratadine Syrup 1 mg/mL 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 and Hydrochlorothiazide Tablets 50 mg/12.5 mg
and 100 mg/25 mg
Hyzaar 5/24/2004
Mefloquine Hydrochloride Tablets 250 mg Lariam
Megestrol Acetate Oral Suspension 40 mg/mL Megace
Metaxalone Tablets 400 mg  Skelaxin
Metformin Hydrochloride Extended-release Tablets 500 mg Glucophage XR  
Metformin Hydrochloride Extended-release Tablets 750 mg Glucophage XR  
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
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

1/15/2004
Mometasone Furoate 

 

Mometasone Furoate 

Topical Solution (Cream)

Topical Solution
(Lotion)

0.1%

 

0.1%

Elocon

 

Elocon

 

 

6/10/2004

Moxifloxacin Hydrochloride Tablets 400 mg Avelox  
Nabumetone Tablets 500 mg and 750 mg Relafen  
Naproxen Sodium Extended-release Tablets 375 mg (base) and 500 mg (base) Naprelan  
Nefazodone HCl Tablets 50 mg, 100 mg, 150 mg  200 mg and 250 mg Serzone  
Niacin Extended-release Tablets 500 mg, 750 mg and 1000 mg Niaspan  
Nicotine Transdermal System 7 mg/day, 14 mg/day and           21 mg/day Habitrol  
Nicotine Polacrilex Troche/Lozenge 2 mg and 4 mg Commit  
Nifedipine Capsules 10 mg and 20 mg Procardia  
Nifedipine Extended-release Tablets 30 mg, 60 mg and 90 mg Adalat CC  
Nifedipine Extended-release Tablets 30 mg, 60 mg and 90 mg Procardia XL  
Nitrofurantoin Monohydrate/Macrocrystals  Capsules 75 mg/25 mg Macrobid
Nitroglycerin Transdermal System 0.1 mg/hr Transderm-Nitro
Nitroglycerin Transdermal System 0.1 mg/hr, 0.2 mg/hr, 0.3 mg/hr, 0.4 mg/hr, 0.6 mg/hr and          0.8 mg/hr Nitro-dur  
Nizatidine Capsules 150 mg and 300 mg Axid  
Norethindrone/ Ethinyl Estradiol Tablets 0.5 mg/ 0.035 mg, 0.75 mg/ 0.035 mg and 1 mg /0.035 mg Ortho-Novum 7/7/7, 21 and 28 day  
Norethindrone Acetate/Ethinyl Estradiol Tablets 1 mg/0.005 mg Femhrt  
Norethindrone Acetate/Ethinyl Estradiol Tablets 1 mg/  0.02 mg,     1 mg/0.03 mg and 1 mg /0.035 mg Estrostep Fe  
Norethindrone Acetate/Ethinyl Estradiol Tablets 1 mg/0.02 mg,     1 mg/ 0.03 mg and 1 mg /0.035 mg Estrostep 21  
Norgestimate/ Ethinyl Estradiol Tablets 0.18 mg /0.035 mg, 0.215 mg /0.035 mg and 0.25 mg /0.035 mg Ortho Tri-Cyclen, 21 and 28 day  
Norgestimate/ Ethinyl Estradiol Tablets 0.18 mg /0.025 mg, 0.215 mg /0.025 mg and 0.25 mg /0.025 mg Ortho Tri-Cyclen Lo, 28 day  
Nortriptyline Hydrochloride Capsules 10 mg, 25 mg,      50 mg and 75 mg Pamelor  
Octreotide Acetate Injection 0.05 mg /mL, 0.1 mg /mL and   0.5 mg/mL, 1 mL vials Sandostatin (Preservative-free)  
Octreotide Acetate Injection 0.2 mg/mL and 1 mg /mL, 5 mL vials Sandostatin  
Ofloxacin Otic Solution 0.3% Floxin
Olanzapine Tablets 2.5 mg, 5 mg,  7.5 mg, 10 mg and 15 mg Zyprexa  
Olanzapine Tablets 20 mg Zyprexa
Olanzapine Orally Disintegrating Tablets 5 mg, 10 mg, 15 mg and 20 mg Zyprexa Zydis  
Omeprazole Delayed-release Capsules 10 mg, 20 mg and 40 mg Prilosec  
Ondansetron Hydrochloride Tablets 4 mg, 8 mg, 16 mg and 24 mg Zofran  
Ondansetron Hydrochloride Orally Disintegrating Tablets 4 mg and 8 mg Zofran ODT  
Ondansetron Hydrochloride Injection 2 mg/mL, 20 mL vials Zofran  
Ondansetron Hydrochloride Injection 2 mg/mL,              2 mL vials (Preservative-free) Zofran  
Ondansetron Hydrochloride Injection 0.64 mg/mL, 50 mL container (plastic) Zofran in Plastic Container  
Oxazepam Capsules 10 mg, 15 mg and 30 mg Serax  
Oxybutynin Chloride  Extended-release Tablets 5 mg, 10 mg and 15 mg Ditropan XL  
Oxycodone Extended- release Tablets 10 mg, 20 mg,  
40 mg, 80 mg 
and 160 mg
Oxycontin  
Paclitaxel Injection 6 mg/mL,  5 mL,  16.7 mL, 25 mL,  33.3 mL and 50 mL vials Taxol  
Pamidronate Disodium For Injection 30 mg/vial, 60 mg/vial and       90 mg/vial Aredia  
Pamidronate Disodium Injection 30 mg/vial, 60 mg/vial and      90 mg/vial Aredia  
Pantoprazole Sodium
 
Delayed-release Tablets 20 mg and
40 mg
Protonix 2/02/2004
Paroxetine Hydrochloride Tablets 10 mg, 20 mg,   30 mg and
40 mg
Paxil  
Paroxetine Hydrochloride Capsules 10 mg and 20 mg Paxil  
Pergolide Mesylate Tablets 0.05 mg, 0.25 mg and 1 mg Permax  
Pioglitazone Hydrochloride Tablets 15 mg, 30 mg and 45 mg Actos  
Polyethylene Glycol 3350  Powder for Oral Solution 17g/Scoopful Miralax  
Potassium Chloride Extended-release Tablets 10 mEq and 20 mEq K-Dur  
Potassium Chloride Extended-release Capsules 8 mEq and 10 mEq Micro K  
Pravastatin Sodium Tablets 10 mg, 20 mg, 
40 mg and 80 mg
Pravachol  
Prazosin Hydrochloride Capsules 1 mg, 2 mg and 5 mg Minipress  
Prednisolone Sodium Phosphate Oral Solution 5 mg(base)/ 5 mL and 15 mg (base)/ 5 mL Pediapred  
Propofol Injection 10 mg/mL ; 20 mL, 50 mL and 100 mL vials and   20 mL syringe Diprivan  
Propranolol Hydrochloride Extended-release Capsules 60 mg, 80 mg,   120 mg and 160 mg Inderal LA  
Quinapril Hydrochloride Tablets 5 mg, 10 mg, 20 mg and 40 mg Accupril  
Quinapril Hydrochloride/Hydrochlorothiazide Tablets 10 mg/12.5 mg, 20 mg/12.5 mg and 20mg/25 mg Accuretic  
Rabeprazole Sodium Delayed-release Tablets 20 mg Aciphex  
Raloxifene Hydrochloride Tablets 60 mg Evista
Ramipril Capsules 1.25 mg, 2.5 mg, 5 mg and 10 mg Altace  
Ranitidine