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U.S. Department of Health and Human Services

Drugs

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'T'

 

 

Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient
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
Tacrolimus (PDF - 80KB)Revised Draft Topical Ointment 0.1% 50777 11/2013
Tacrolimus (PDF - 77KB)Revised Draft Topical Ointment 0.03% 50777 11/2013
Tacrolimus (PDF - 16KB)Revised Draft Oral Capsule 50708 12/2012
Tadalafil (PDF - 33KB)Revised Draft Oral Tablet 21368 9/2012
Tamoxifen Citrate (PDF - 29KB) Final Oral Tablet

74858

75797

10/2011
Tamsulosin HCl (PDF - 46KB) Final Oral Capsule 20579 5/2008
 Tapentadol HCl (PDF - 41KB)  Draft  Oral Tablet, Extended Release 200533  6/2012
Tapentadol HCl (PDF - 37KB) Draft Oral Tablet 22304 11/2010
Tazarotene 0.05 (PDF - 240KB) Draft Topical Cream 21184 4/2011
Tazarotene 0.05 (PDF - 251 KB) Draft Topical Gel 20600 4/2011
Tazarotene 0.1 (PDF - 224KB) Draft Topical Cream 21184 6/2011
Tazarotene 0.1 (PDF - 231KB) Draft Topical Gel 20600 6/2011

 

Telaprevir (PDF - 17KB)

Draft Oral Tablet 201917 9/2012
Telbivudine (PDF - 32KB) Final Oral Tablet 22011 10/2011
Telithromycin (PDF - 47KB) Final Oral Tablet 21144 5/2008
Telmisartan (PDF - 49KB)Revised Final Oral Tablet 20850 10/2010
Temazepam (PDF - 30KB) Final Oral Capsule 18163 10/2011
Temozolomide (PDF - 19KB)
Revised
Draft Oral Capsule 21029 7/2009

 

Tenofovir Disoproxil Fumarate (PDF - 17KB)

Draft Oral Powder 022577 9/2012
Tenofovir Disoproxil Fumarate (PDF - 17KB) Revised Draft Oral Tablet 21356 6/2013
Terazosin HCl (PDF - 45KB) Final Oral Capsule 74823 5/2008
Terbinafine Hydrochloride (PDF - KB) Draft Topical Cream 20980 8/2010
Terbinafine HCl (PDF - 31KB) Final Oral Granules 22071 10/2011
Terbinafine HCl (PDF - 47KB) Final Oral Tablet 20539 5/2008
Terconazole (PDF - 114KB) Draft Vaginal Cream 19579 2/2010
Terconazole (PDF - 114KB) Draft Vaginal Cream 19964 2/2010
Terconazole (PDF - 114KB) Draft Vaginal Suppository 19641 2/2010
Teriflunomide (PDF - 35KB) Draft Oral Tablet 202992 4/2014
Testosterone (PDF -27KB)1%Revised Draft Transdermal Gel, Metered 21015 11/2013
Testosterone (PDF - 27KB) 1.62%Revised Draft Transdermal Gel, Metered 22309 11/2013
Testosterone (PDF - 26KB) 10 mg/0.5 gm gel Draft Transdermal Gel, Metered 21463 4/2013
Testosterone (PDF - 27KB)1%Revised Draft Transdermal Gel 21015 11/2013
Testosterone (PDF - 27KB) 1% Draft Transdermal Gel 21454 4/2013
Testosterone (PDF - 27KB) 1.62%Revised Draft Transdermal Gel 22309 11/2013
Testosterone (PDF - 21KB) Draft Transdermal Solution, Metered 22504 4/2013
 Tetrabenazine (PDF - 46KB)  Draft  Oral Tablet 21894  6/2012
Testosterone (PDF - 41KB) Draft Implantation  Pellet 80911 8/2011
Testosterone (PDF - 77KB) Final Oral Tablet, Extended Release, Buccal 21543 5/2008
Tetracycline HCl (PDF - 16KB) Draft Oral Capsule 60704 2/2010
Thalidomide (PDF -20KB)Revised Draft Oral Capsule

20785

21430

12/2012
Theophylline (PDF - 30KB) Draft Oral Tablet, Extended Release

40086 

87571

2/2010
Theophylline (PDF - 33KB) Draft Oral Tablet, Extended Release

81236 

89763 

89808

89807

2/2010
Theophylline (PDF - 18KB)Revised Draft Oral Capsule, Extended Release

87942 

87943 

87944

81034

9/2012
Thioguanine (PDF - 18KB) Draft Oral Tablet 012429 9/2012
Tiagabine HCl (PDF - 39KB) Revised Draft Oral Tablet 20646 8/2010
Ticlopidine HCl (PDF - 46KB) Final Oral Tablet 19979 5/2008

 Timolol Maleate (PDF - 22KB)

Draft Oral Tablet 072668 6/2013
Tinidazole (PDF - 26KB)Revised Draft Oral Tablet 21618 12/2012
Tioconazole (PDF - 165KB) Draft Vaginal Ointment 20676 3/2011
Tipranavir (PDF - 39KB) Draft Oral Capsule 21814 11/2007
Tizanidine HCl (PDF - 38KB) Draft Oral Tablets 20397 11/2010
Tizanidine HCl (PDF - 48KB) Final Oral Capsule 21447 5/2008
Tolterodine Tartrate (PDF - 52KB) Final Oral Tablet 20771 5/2008
Tolterodine Tartrate (PDF - 19KB)Revised Draft Oral Capsules, Extended Release 21228 9/2012
Tolvaptan (PDF - 19KB) Draft Oral Tablet 22275 3/2012
Topiramate (PDF - 35KB)
Revised
Draft Oral Tablet 20505 6/2013
Topiramate (PDF - 17KB)
Revised
Draft Oral Capsule, Sprinkle 20844 6/2013
Topotecan HCl (PDF - 53 KB) Draft Oral Capsule 20981 3/2011
Toremifene Citrate (PDF - 30KB) Final Oral Tablet 20497 10/2011
Torsemide (PDF - 50KB) Final Oral Tablet 20136 5/2008
Tramadol HCl (PDF - 41KB) Final Oral Tablet 20281 5/2008
Tramadol HCl (PDF - 43KB) Draft Oral Tablet, Extended Release 21692 11/2007
Trandolapril (PDF - 49KB) Final Oral Tablet 20528 5/2008
Trandolapril; Verapamil HC (PDF - 18KB)l Draft Oral Tablet, Extended Release 20591 12/2008
Tranexamic Acid (PDF - 32KB) Revised Draft Oral Tablet 22430 3/2011
Tranylcypromine Sulfate (PDF - 24KB) Draft Oral Tablet 12342 4/2014
Trazodone HCl (PDF - 50KB)Revised Draft Oral Tablet, Extended Release 22411 9/2012
Trazodone HCl (PDF - 39KB) Draft Oral Tablet

71196 

71258

2/2010

 

Tretinoin (PDF -135KB) (NDA 019963)

Draft Topical Cream 19963 9/2012
Tretinoin (PDF -132KB) (NDA 021108) Draft Topical Cream 21108 9/2012
Tretinoin (PDF -133KB) (NDA 020475) Draft Topical Gel (0.1%) 20475 9/2012
Tretinoin (PDF -133KB) (NDA 020475) Draft Topical Gel (0.04%) 20475 9/2012
Tretinoin (PDF - 117KB) Draft Topical Cream 17340 3/2012
Tretinoin (PDF - 117KB) Draft Topical Cream 17522 3/2012
Tretinoin (PDF - 117KB) Draft Topical Cream 19049 3/2012
Tretinoin (PDF - 117KB) Draft Topical Cream 90098 3/2012
Tretinoin (PDF - 116KB) Draft Topical Gel 17579 3/2012
Tretinoin (PDF - 126KB) Draft Topical Gel 17955 3/2012
Tretinoin (PDF - 126KB) Draft Topical Gel 22070 3/2012
Tretinoin (PDF - 129KB) Draft Topical Solution 16921 3/2012
Tretinoin (PDF - 36KB) Draft Oral Capsule 77684 9/2010
Triamcinolone Acetonide (PDF - 29KB) Draft Dental Paste 70730 3/2011
Triamcinolone Acetonide (PDF - 36KB) Revised Draft Injectable Suspension

12041 

14901

2/2011
Triamterene (PDF - 40KB) Final Oral Capsule 13174 5/2008
Triazolam (PDF - 33KB) Draft Oral Tablet 17892 8/2010

 Trientine HCl (PDF - 22KB)

Draft Oral Capsule 019194 6/2013
Trimethoprim (PDF - 17KB) Draft Oral Tablet

18679

2/2010
Triptorelin Pamoate (PDF - 15KB) Revised Draft Intramuscular Injectable

20715

21288

2/2014
Trospium Chloride (PDF - 23KB) Draft Oral Capsule, Extended Release 22103 8/2008
Trospium Chloride (PDF - 36KB) Draft Oral Tablet 21595 11/2007