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Guidance for Industry:
Individual Product Bioequivalence Recommendations

Draft Guidance for Industry: Bioequivalence Recommendations for Specific Products (Issued May, 2007) Individual Recommendations

 


Newly Added Recommendations (count 30 new)
Active Ingredient
(link to Specific Guidance)		 Type Route of Administration Dosage Form RLD
Application Number
(link to Orange Book)		 Date
Recommended
 
Albuterol Sulfate Draft Oral Tablet 72894 8/2008
Aliskiren Hemifumarate Draft Oral Tablet 21985 8/2008
Amlodipine Besylate; Valsartan Draft Oral Tablet 21990 8/2008
Amprenavir Draft Oral Capsule 21007 8/2008
Azacitidine Draft Oral Injection 50794 8/2008
Citalopram Hydrobromide Draft Oral Tablet 20822 8/2008
Cyclobenzaprine HCl Draft Oral Capsule, Extended Release 21777 8/2008
Desogestrel; Ethinyl Estradiol Draft Oral Tablet 20713 8/2008
Disopyramide Phosphate Draft Oral Capsule 17447 8/2008
Doxercalciferol Draft Oral Capsule 20862 8/2008
Doxycycline Draft Oral Suspension 50006 8/2008
Enalapril Maleate Draft Oral Tablet 18998 8/2008
Famciclovir Draft Oral Tablet 20363 8/2008
Fexofenadine HCl Draft Oral Tablet, Orally Disintegrating 21909 8/2008
Hydroxyurea Draft Oral Capsule 16295 8/2008
Levofloxacin Draft Oral Tablet 20634 8/2008
Lopinavir; Ritonavir Draft Oral Capsule 21226 8/2008
Midodrine HCl Draft Oral Tablet 19815 8/2008
Olanzapine Draft Oral Tablet 20592 8/2008
Paroxetine HCl Draft Oral Tablet 20031 8/2008
Penicillamine Draft Oral Capsule 19853 8/2008
Prednisolone Sodium Phosphate Draft Oral Tablet, Orally Disintegrating 21959 8/2008
Ramipril Draft Oral Tablet 22021 8/2008
Repaglinide Draft Oral Tablet 20741 8/2008
Simvastatin Draft Oral Tablet, Orally Disintegrating 21961 8/2008
Stavudine Draft Oral Capsule 20412 8/2008
Sulfamethoxazole; Trimethoprim Draft Oral Tablet 17377 8/2008
Trospium Chloride Draft Oral Capsule, Extended Release 22103 8/2008
Valganciclovir HCl Draft Oral Tablet 21304 8/2008
Vorinostat Draft Oral Capsule 21991 8/2008
 

Individual Recommendations (count 335)

A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

 
Active Ingredient
(link to Specific Guidance)		 Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)		 Date
Recommended
A
Abacavir Sulfate Final

Oral

 Tablet 20977 5/2008
Abacavir Sulfate; Lamivudine Draft Oral Tablet 21652 11/2007
Abacavir Sulfate; Lamivudine; Zidovudine Final Oral Tablet 21205 5/2008
Acamprosate Calcium Final Oral Tablet, Delayed Release 21431 5/2008
Acetazolamide Draft Oral Tablets 40195 7/2008
Acitretin Draft Oral Capsule 19821 5/2007
Acyclovir Final Oral Tablet 20089 5/2008
Adefovir Dipivoxil Draft Oral Tablet 21449 7/2008
Alendronate Sodium Draft Oral Tablet 20560 1/2008
Alfuzosin HCl Draft Oral Tablet, Extended Release 21287 11/2007
Almotriptan Malate Final

Oral

 Tablet 21001 5/2008
Alosetron HCl Final

Oral

 Tablet 21107 5/2008
Alprazolam Draft Oral Tablet, Extended Release 21434 11/2007
Alprazolam Final Oral Tablet 18276 5/2008
Aminosalicylic Acid Draft Oral Granules, Delayed Release 74346 7/2008
Amlodipine Besylate Final

Oral

 Tablet 19787 5/2008
Amlodipine Besylate; Benazepril HCl Final

Oral

 Tablet 20364 5/2008
Amoxicillin; Clavulanate Potassium Draft Oral Tablet, Chewable 50597 1/2008
Amoxicillin; Clavulanate Potassium Draft Oral Tablet, Chewable 50726 1/2008
Amoxicillin; Clavulanate Potassium Final Oral Suspension

50755
50725

 5/2008
Amprenavir Draft Oral Capsule 21007 2/2008
Anagrelide HCl Final Oral Capsule 76468 5/2008
Anastrozole Final Oral Tablet 20541 5/2008
Aprepitant Final Oral Capsule 21549 5/2008
Aripiprazole Draft Oral Tablet 21436 11/2007
Armodafinil Draft Oral Tablet 21875 1/2008
Atazanavir Sulfate Final Oral Capsule 21567 5/2008
Atomoxetine HCl Final Oral Capsule 21411 5/2008
Atorvastatin Calcium Final

Oral

 Tablet 20702 5/2008
Atovaquone Draft Oral Tablet 20259 11/2007
Atovaquone; Proguanil Draft Oral Tablet 21078 7/2008
Azithromycin Draft Oral Suspension, Extended Release 50797 7/2008
Azithromycin Draft Oral Tablet

50730
50711
50784

 1/2008
B
Baclofen Draft Oral Tablet, Orally Disintegrating 21589 7/2008
Balsalazide Disodium Draft Oral Capsule 20610 1/2008
Benzonatate Final Oral Capsule 11210 5/2008
Benzphetamine HCl Final Oral Capsule 12427 5/2008
Bicalutamide Final Oral Tablet 20498 5/2008
Bisoprolol Fumarate Final Oral Tablet 19982 5/2008
Bisoprolol Fumarate; Hydrochlorothiazide Final Oral Tablet 20186 5/2008
Bumetanide Draft Oral Tablet 18225 7/2008
Bupropion HCl
Revised
Draft Oral Tablet, Extended Release 21515 4/2008
Busulfan Draft Oral Tablet 09386 7/2008
C
Calcitriol Draft Oral Capsule 18044 7/2008
Candesartan Cilexetil Final Oral Tablet 20838 5/2008
Candesartan Cilexetil; Hydrochlorothiazide Final Oral Tablet 21093 5/2008
Capecitabine Draft Oral Tablet 20896 7/2008
Carbamazepine Draft Oral Tablet, Extended Release 20234 2/2008
Carbamazepine Draft Oral Capsule, Extended Release 20712 11/2007
Carbamazepine Final Oral Suspension 18927 5/2008
Carbidopa; Entacapone; Levodopa Draft Oral Tablet 21485 5/2007
Carvedilol Final Oral Tablet 20297 5/2008
Cefdinir Draft Oral Capsule 50739 1/2008
Cefditoren Pivoxil Final Oral Tablet 21222 5/2008
Cefixime Draft Oral Suspension

65129

65355

 1/2008
Celecoxib Draft Oral Capsule 20998 5/2007
Cetirizine HCl Final Oral

Tablet, Chewable

21621 5/2008
Cetirizine HCl; Pseudoephedrine HCl Draft Oral Tablet, Extended Release 21150 2/2008
Cevimeline HCl Final Oral Capsule 20989 5/2008
Cilostazol Final Oral Tablet 20863 5/2008
Cinacalcet HCl Final Oral Tablet 21688 5/2008
Ciprofloxacin HCl Draft Oral Tablet, Extended Release 21744 11/2007
Ciprofloxacin; Ciprofloxacin HCl Draft Oral Tablet, Extended Release 21473 1/2008
Clarithromycin Draft Oral Tablet, Extended Release 50775 1/2008
Clarithromycin Final Oral Suspension 50698 5/2008
Clonidine HCl Final Oral Tablet 17407 5/2008
Clopidogrel Bisulfate
Revised
Draft Oral Tablet 20839 8/2008
Colesevelam HCl Draft Oral Tablet 21176 7/2008
D
Danazol Final Oral Capsule 74582 5/2008
Dantrolene Sodium Draft Oral Capsule 76856 5/2007
Darifenacin HBr Final Oral Tablet, Extended Release 21513 5/2008
Darunavir Ethanolate Draft Oral Tablet 21976 11/2007
Deferasirox Final Oral Tablet, For Suspension 21882 5/2008
Delavirdine Mesylate Draft Oral Tablet 20705 11/2007
Desloratadine Final Oral Tablet, Orally Disintegrating 21312 5/2008
Desloratadine Final Oral Tablet 21165 5/2008
Dexmethylphenidate Draft Oral Tablet 21278 2/2008
Dextromethorphan Polistirex Final Oral Suspension, Extended Release 18658 5/2008
Diclofenac Sodium; Misoprostol Final Oral Tablet, Delayed Release 20607 5/2008
Dicloxacillin Sodium Final Oral Capsule 61454 5/2008
Didanosine Final Oral Tablet, Chewable 20154 5/2008
Didanosine Final Oral Capsule, Delayed Release Pellets 21183 5/2008
Diflunisal Draft Oral Tablet 74400 7/2008
Digoxin Final Oral Tablet 20405 5/2008
Diltiazem HCl Draft Oral Capsule, Extended Release 20062 2/2008
Diltiazem HCl Draft Oral Capsule, Extended Release 20092 2/2008
Diltiazem HCl Draft Oral Capsule, Extended Release 20401 2/2008
Diltiazem HCl Draft Oral Tablet, Extended Release 21392 2/2008
Dipyridamole Final Oral Tablet 12836 5/2008
Divalproex Sodium Final Oral Capsule, Delayed Release Pellets 19680 5/2008
Divalproex Sodium Draft Oral Tablet, Extended Release 21168 2/2008
Dofetilide Final Oral Capsule 20931 5/2008
Donepezil HCl Final Oral Tablet, Orally Disintegrating 21720 5/2008
Donepezil HCl Final Oral Tablet 20690 5/2008
Doxazosin Mesylate Final Oral Tablet, Extended Release 21269 5/2008
Doxycycline Draft Oral Capsule, Delayed Release 50805 2/2008
Doxycycline Draft Oral Tablet 65070 1/2008
Doxycycline Hyclate Draft Oral Capsule 50007 7/2008
Drospirenone; Estradiol Final Oral Tablet 21355 5/2008
Duloxetine HCl Final Oral Capsule, Delayed Release Pellets 21427 5/2008
Dutasteride Final Oral Capsule 21319 5/2008
E
Efavirenz Final Oral Capsule 20972 5/2008
Efavirenz Final Oral Tablet 21360 5/2008
Emtricitabine Final Oral Capsule 21500 5/2008
Entacapone Final Oral Tablet 20796 5/2008
Entecavir Final Oral Tablet 21797 5/2008
Eplerenone Final Oral Tablet 21437 5/2008
Eprosartan Mesylate Draft Oral Tablet 20738 7/2008
Eprosartan Mesylate; Hydrochlorothiazide Draft Oral Tablet 21268 2/2008
Erlotinib HCl Final Oral Tablet 21743 2/2008
Escitalopram Oxalate Final Oral Tablet 21323 5/2008
Esomeprazole Magnesium Final Oral Capsule, Delayed Release Pellets 21153 5/2008
Estrogens, Esterified Draft Oral Tablet

84948
84949
84950
84951

 2/2008
Eszopiclone Draft Oral Tablet 21476 1/2008
Ethambutol HCl Draft Oral Tablet 75095 1/2008
Ethinyl Estradiol; Levonorgestrel Draft Oral Tablet 21840 2/2008
Ethinyl Estradiol; Levonorgestrel Draft Oral Tablet 21544 2/2008
Ethinyl Estradiol; Norethindrone Acetate Draft Oral Tablet 20130 7/2008
Ethinyl Estradiol; Norethindrone Acetate Draft Oral Tablet 21065 7/2008
Ethosuximide Draft Oral Capsule 12380 7/2008
Etidronate Disodium Final Oral Tablet 17831 5/2008
Exemestane Final Oral Tablet 20753 5/2008
F
Famotidine Final Oral Tablet, Orally Disintegrating 21712 5/2008
Famotidine Final Oral Tablet

19462
20325

 5/2008
Felbamate Draft Oral Tablet 20189 8/2007
Felbamate Draft Oral Suspension 20189 8/2007
Fenofibrate Draft Oral Capsule 21612 2/2008
Fenofibrate Final Oral Capsule 21695 5/2008
Fenofibrate Final Oral Tablet 21656 5/2008
Fexofenadine HCl Final Oral Capsule 20625 5/2008
Fexofenadine HCl Final Oral Tablet 76191 5/2008
Flavoxate HCl Draft Oral Tablet 16769

5/2007
Fluconazole Final Oral Tablet 19949 5/2008
Fluvastatin Sodium Draft Oral Capsule 20261 1/2008
Fluvastatin Sodium Draft Oral Tablet, Extended Release 21192 1/2008
Fluoxetine HCl;
Olanzapine		 Final Oral Capsule 21520 5/2008
Fosamprenavir Calcium Draft Oral Suspension 22116 11/2007
Fosamprenavir Calcium Final Oral Tablet 21548 5/2008
Fosinopril Sodium Final Oral Tablet 19915 5/2008
Fosinopril Sodium; Hydrochlorothiazide Final Oral Tablet 20286 5/2008
G
Gabapentin Draft Oral Capsule 20235 5/2007
Gabapentin Final Oral Tablet 20882 5/2008
Galantamine HBr Draft Oral Capsule, Extended Release 21615 5/2007
Ganciclovir Draft Oral Capsule 19661 8/2007
Gatifloxacin 0.3% Draft Ophthalmic Solution 21493 7/2008
Gemifloxacin Mesylate Final Oral Tablet 21158 5/2008
Glimepiride Final Oral Tablet 20496 5/2008
Glimepiride; Rosiglitazone Maleate Draft Oral Tablet 21700 11/2007
Glipizide Draft Oral Tablet, Extended-Release 20329 7/2008
Glipizide; Metformin HCl Final Oral Tablet 21460 5/2008
Glyburide; Metformin HCl Final Oral Tablet 21178 5/2008
Granisetron HCl Final Oral Tablet 20305

5/2008
H
Hydralazine HCl Draft Oral Tablet

89098

89097

88467

88468

 7/2008
Hydrochlorothiazide Final Oral Capsule 20504 5/2008
Hydrochlorothiazide; Irbesartan Final Oral Tablet 20758 5/2008
Hydrochlorothiazide; Lisinopril Final Oral Tablet 19888 5/2008
Hydrochlorothiazide; Losartan Potassium Final Oral Tablet 20387 5/2008
Hydrochlorothiazide; Olmesartan Medoxomil Final Oral Tablet 21532 5/2008
Hydrochlorothiazide and Telmisartan Draft Oral Tablet 21162 7/2008
Hydrochlorothiazide; Valsartan
Revised
Draft Oral Tablet 20818 7/2008
I
Ibandronate Sodium Final Oral Tablet 21455 5/2008
Ibuprofen; Pseudoephedrine HCl
 Draft Oral Suspension 21128 8/2007
Indapamide Draft Oral Tablet 74461 7/2008
Indinavir Sulfate Final Oral Capsule 20685 5/2008
Irbesartan Final Oral Tablet 20757 5/2008
Isoniazid Draft Oral Tablet 08678 7/2008
Isosorbide Mononitrate Final Oral Tablet, Extended Release 20225 5/2008
Isradipine Final Oral Capsule 77317 5/2008
Isradipine Final Oral Tablet, Extended Release 20336 5/2008
Itraconazole Draft Oral Capsule 20083 5/2007
K
Ketoconazole USP, 2% Draft Topical Shampoo (Suspension) 19927 7/2008
Ketorolac Tromethamine Draft Oral Tablet 74761 7/2008
L
Lamivudine Draft Oral Tablet 21003 11/2007
Lamivudine Final Oral Tablet 20564 5/2008
Lamivudine; Zidovudine Final Oral Tablet 20857 5/2008
Lamotrigine Final Oral Tablet, Chewable 20764 5/2008
Lamotrigine Final Oral Tablet 20241 5/2008
Leflunomide Draft Oral Tablet 20905 8/2007
Letrozole Draft Oral Tablet 20726 7/2008
Leucovorin Calcium Draft Oral Tablet

72733

72734

72735

72736 

 7/2008
Leuprolide Acetate Draft Implantation Implant 21088 7/2008
Levonorgestrel Final Oral Tablet 21045 5/2008
Lidocaine Draft Topical Patch 20612 5/2007
Linezolid Draft Oral Tablet 21130 1/2008
Liothyronine Sodium Final Oral Tablet 10379 5/2008
Lisinopril Draft Oral Tablet 19777 1/2008
Lithium Carbonate Draft Oral Capsule 17812 7/2008
Lopinavir; Ritonavir Draft Oral Tablet 21906 11/2007
Loratadine Draft Oral Tablet 19658 7/2008
Loratadine Final Oral Tablet, Orally Disintegrating 20704 5/2008
Losartan Potassium Final Oral Tablet 20386 5/2008
M
Mefloquine HCl Final Oral Tablet 19591 5/2008
Meloxicam Final Oral Suspension 21530 5/2008
Meloxicam Final Oral Tablet 20938 5/2008
Melphalan Draft Oral Tablet 14691 7/2008
Memantine HCl Draft Oral Tablet 21487 1/2008
Mercaptopurine Final Oral Tablet 09053 5/2008
Mesalamine Draft Rectal Enema 19618 1/2008
Mesalamine Draft Rectal Suppository 21252 5/2007
Metaxalone Draft Oral Tablet 13217 5/2007
Metformin HCl Draft Oral Tablet 20357 7/2008
Metformin HCl Final Oral Tablet, Extended Release 21202 5/2008
Metformin HCl; Pioglitazone Final Oral Tablet 21842 5/2008
Methadone HCl Draft Oral Tablet

06134

17058

 7/2008
Metoprolol Succinate
Revised
Draft Oral Tablet, Extended Release 19962 4/2008
Miglustat Final Oral Capsule 21348 5/2008
Minocycline HCl Draft Oral Capsule

63009

63011

 7/2008
Minocycline HCl Draft Oral Tablet, Extended Release 50808 11/2007
Minoxidil
Revised
Draft Oral Tablet 18154 7/2008
Mirtazapine Final Oral Tablet, Orally Disintegrating 21208 5/2008
Modafinil Final Oral Tablet 20717 5/2008
Moexipril HCl Final Oral Tablet 20312 5/2008
Montelukast Draft Oral Granule 21409 7/2008
Montelukast Draft Oral Tablet 20829 7/2008
Montelukast Sodium
Revised
Final Oral Tablet, Chewable 20830 7/2008
Morphine Sulfate
Revised
Draft Oral Capsule, Extended Release 20616 4/2008
Moxifloxacin HCl Draft Oral Tablet 21085 7/2008
Mycophenolate Mofetil Draft Oral Capsule 50722 8/2007
Mycophenolate Mofetil HCl Draft Oral Tablet 50723 8/2007
N
Nabilone Draft Oral Capsule 18677 7/2008
Nabumetone Final Oral Tablet 75189 5/2008
Naproxen Sodium Draft Oral Tablet 17581 7/2008
Naproxen Sodium Draft Oral Tablet 18164 7/2008
Naproxen Sodium Draft Oral Tablet 20204 7/2008
Naratriptan HCl Draft Oral Tablet 20763 7/2008
Nateglinide Final Oral Tablet 21204 5/2008
Nelfinavir Mesylate Draft Oral Suspension 20778 11/2007
Nelfinavir Mesylate Final Oral Tablet

20779

21503

 5/2008
Nevirapine Final Oral Suspension 20933 5/2008
Nevirapine Draft Oral Tablet 20636 11/2007
Nicardipine HCl Draft Oral Capsule, Extended Release 20005 7/2008
O
Olanzapine Final Oral Tablet, Orally Disintegrating 21086 5/2008
Olmesartan Medoxomil Final Oral Tablet 21286 5/2008
Olsalazine Sodium Final Oral Capsule 19715 5/2008
Omeprazole Final Oral Capsule, Delayed Release 19810 5/2008
Omeprazole Magnesium Final Oral Tablet, Delayed Release 21229 5/2008
Omeprazole; Sodium Bicarbonate Draft Oral Capsule 21849 7/2008
Omeprazole; Sodium Bicarbonate Final Oral Suspension 21636 5/2008
Omeprazole, Sodium Bicarbonate; Magnesium Hydroxide Draft Oral Tablet, Chewable 21850 2/2008
Ondansetron Final Oral Tablet, Orally Disintegrating 20781 5/2008
Ondansetron HCl Final Oral Tablet 20103 5/2008
Oxcarbazepine Final Oral Suspension 21285 5/2008
Oxcarbazepine Final Oral Tablet 21014 5/2008
Oxymorphone HCl Draft Oral Tablet 21611 1/2008
Oxymorphone HCl Draft Oral Tablet, Extended Release 21610 11/2007
P
Paliperidone Draft Oral Tablet, Extended Release 21999 11/2007
Pantoprazole Sodium Final Oral Tablet, Delayed Release 20987 5/2008
Paricalcitol Draft Oral Capsule 21606 11/2007
Perindopril Erbumine Final Oral Tablet 20184 5/2008
Phenoxybenzamine Draft Oral Capsule 08708 7/2008
Phenytoin Sodium Final Oral Capsule, Extended 84349 5/2008
Phenytoin Sodium Final Oral Capsule, Extended 40298 5/2008
Phenytoin Draft Oral Tablet, Chewable 84427 1/2008
Phenytoin Final Oral Suspension 08762 5/2008
Pilocarpine HCl Final Oral Tablet 20237 5/2008
Pimozide Draft Oral Tablet 17473 2/2008
Posaconazole Draft Oral Suspension 22003 11/2007
Pravastatin Sodium Final Oral Tablet 19898 5/2008
Q
Quetiapine Fumarate Draft Oral Tablet, Extended Release 22047 7/2008
Quetiapine Fumarate Final Oral Tablet 20639 5/2008
Quinapril HCl Final Oral Tablet 19885 5/2008
Quinine Sulfate Draft Oral Capsule 21799 1/2008
R
Raloxifene HCl Final Oral Tablet 20815 5/2008
Ramipril Final Oral Capsule 19901 5/2008
Ribavirin Final Oral Capsule 20903 5/2008
Ribavirin Final Oral Tablet 77456 5/2008
Rifampin Final Oral Capsule

50420

62303

 5/2008
Riluzole Final Oral Tablet 20599 5/2008
Risedronate Sodium; Calcium Carbonate Final Oral Tablet 21823 5/2008
Risedronate Sodium
Revised
Draft Oral Tablet 20835 1/2008
Risperidone Draft Oral Tablet 20272 5/2007
Ritonavir Final Oral Capsule 20945 5/2008
Rizatriptan Benzoate Final Oral Tablet 20864 5/2008
Rosiglitazone Maleate Final Oral Tablet 21071 5/2008
Rosuvastatin Calcium Final Oral Tablet 21366 5/2008
S
Saquinavir Mesylate Draft Oral Capsule 20628 11/2007
Saquinavir Mesylate Draft Oral Tablet 21785 11/2007
Sevelamer HCl Draft Oral Tablet 21179 7/2008
Sertraline HCl Final Oral Tablet 19839 5/2008
Sibutramine HCl Final Oral Capsule 20632 5/2008
Sildenafil Citrate Final Oral Tablet 20895 5/2008
Simvastatin Final Oral Tablet 19766 5/2008
Sirolimus Final Oral Tablet 21110 5/2008
Sodium Iodide, I-123 Draft Oral Capsule 18671 7/2008
Solifenacin Succinate Draft Oral Tablet 21518 2/2008
Stavudine Final Oral Capsule 20412 5/2008
Sulfadiazine Draft Oral Tablet 40091 7/2008
Sulfamethoxazole; Trimethoprim Final Oral Suspension 77612 5/2008
Sumatriptan Succinate Final Oral Tablet 20132 5/2008
T
Tacrolimus Draft Oral Capsule 50708 5/2007
Tadalafil Draft Oral Tablet 21368 5/2007
Tamsulosin HCl Final Oral Capsule 20579 5/2008
Telithromycin Final Oral Tablet 21144 5/2008
Telmisartan Final Oral Tablet 20850 5/2008
Tenofovir Disoproxil Fumarate Draft Oral Tablet 21356 11/2007
Terazosin HCl Final Oral Capsule 20347 5/2008
Terbinafine HCl Final Oral Tablet 20539 5/2008
Testosterone Final Oral Tablet, Extended Release, Buccal 21543 5/2008
Tiagabine HCl Draft Oral Tablet 20646 7/2008
Ticlopidine HCl Final Oral Tablet 19979 5/2008
Tinidazole Draft Oral Tablet 21618 11/2007
Tipranavir Draft Oral Capsule 21814 11/2007
Tizanidine HCl Final Oral Capsule 21447 5/2008
Tolterodine Tartrate Final Oral Tablet 20771 5/2008
Topiramate Draft Oral Tablet 20505 5/2007
Topiramate Draft Oral Capsule, Sprinkle 20844 5/2007
Torsemide Final Oral Tablet 20136 5/2008
Tolterodine Tartrate Draft Oral Tablet, Extended Release 21228 1/2008
Tramadol HCl; Acetaminophen Final Oral Tablet 21123 5/2008
Tramadol HCl Final Oral Tablet 20281 5/2008
Tramadol HCl Draft Oral Tablet, Extended Release 21692 11/2007
Trandolapril Final Oral Tablet 20528 5/2008
Triamterene Final Oral Capsule 13174 5/2008
Triptorelin Pamoate Draft Intramuscular Injectable

20715

21288

 7/2008
Trospium Chloride Draft Oral Tablet 21595 11/2007
U
Ursodiol Draft Oral Tablet 20675 7/2008
V
Valacyclovir HCl Final Oral Tablet 20487 5/2008
Valsartan Final Oral Tablet 21283 5/2008
Vardenafil HCl Final Oral Tablet 21400 5/2008
Varenicline Tartrate Draft Oral Tablet 21928 11/2007
Venlafaxine HCl Draft Oral Capsule, Extended Release 20699 5/2007
Verapamil HCl Final Oral Capsule, Extended Release 19614 5/2008
Verapamil HCl Final Oral Capsule, Extended Release 20943 5/2008
Voriconazole Final Oral Suspension 21630 5/2008
Z
Zafirlukast Draft Oral Tablet 20547 2/2008
Zaleplon Final Oral Capsule 20859 5/2008
Zalcitabine Draft Oral Tablet 20199 2/2008
Zidovudine Final Oral Capsule 19655 5/2008
Zidovudine Final Oral Tablet 20518 5/2008
Zileuton Draft Oral Tablet, Extended Release 22052 7/2008
Zileuton Draft Oral Tablet 20471 1/2008
Ziprasidone HCl Draft Oral Suspension 21483 7/2008
Ziprasidone HCl Final Oral Capsule 20825 5/2008
Zolmitriptan
Revised
Draft Oral Tablet, Orally Disintegrating 21231 7/2008
Zolpidem Tartrate Draft Oral Tablet 19908 5/2007
Zonisamide Draft Oral Capsule 20789 1/2008

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Date created: May 29, 2007 Updated: August 22, 2008

  
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