Drugs

Product-Specific Recommendations for Generic Drug Development: 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Tacrolimus (PDF - 80KB)RevisedDraftTopicalOintment 0.1%5077711/2013
Tacrolimus (PDF - 77KB)RevisedDraftTopicalOintment 0.03%5077711/2013
Tacrolimus (PDF - 32KB)DraftOralCapsule, Extended Release2040967/2014
Tacrolimus (PDF - 16KB)RevisedDraftOralCapsule5070812/2012
Tadalafil (PDF - 33KB)RevisedDraftOralTablet213689/2012
Tamoxifen Citrate (PDF - 29KB)FinalOralTablet

74858

75797

10/2011
Tamsulosin HCl (PDF - 46KB)FinalOralCapsule205795/2008
 Tapentadol HCl (PDF - 41KB) Draft OralTablet, Extended Release200533 6/2012
Tapentadol HCl (PDF - 37KB)DraftOralTablet2230411/2010

 Tasimelteon  (PDF - 38KB) 

DraftOralCapsule2056779/2015
Tazarotene 0.05 (PDF - 240KB)DraftTopicalCream211844/2011
Tazarotene 0.05 (PDF - 251 KB)DraftTopicalGel206004/2011
Tazarotene 0.1 (PDF - 224KB)DraftTopicalCream211846/2011
Tazarotene 0.1 (PDF - 231KB)DraftTopicalGel206006/2011

 Tedizolid phosphate (PDF - 23KB)

DraftOralTablet2054359/2015

 

Telaprevir (PDF - 17KB)

DraftOralTablet2019179/2012
Telbivudine (PDF - 32KB)FinalOralTablet2201110/2011
Telithromycin (PDF - 47KB)FinalOralTablet211445/2008
Telmisartan (PDF - 49KB)RevisedDraftOralTablet2085010/2010
Temazepam (PDF - 30KB)FinalOralCapsule1816310/2011
Temozolomide (PDF - 19KB)
Revised
DraftOralCapsule210297/2009

 

Tenofovir Disoproxil Fumarate (PDF - 17KB)

DraftOralPowder0225779/2012
Tenofovir Disoproxil Fumarate (PDF - 17KB) RevisedDraftOralTablet213566/2013
Terazosin HCl (PDF - 45KB)FinalOralCapsule748235/2008
Terbinafine Hydrochloride (PDF - KB)DraftTopicalCream209808/2010
Terbinafine HCl (PDF - 31KB)FinalOralGranules2207110/2011
Terbinafine HCl (PDF - 47KB)FinalOralTablet205395/2008
Terconazole (PDF - 114KB)DraftVaginalCream195792/2010
Terconazole (PDF - 114KB)DraftVaginalCream199642/2010
Terconazole (PDF - 114KB)DraftVaginalSuppository196412/2010
Teriflunomide (PDF - 35KB) RevisedDraftOralTablet2029923/2015
Testosterone (PDF -27KB)1%RevisedDraftTransdermalGel, Metered2101511/2013
Testosterone (PDF - 27KB) 1.62%RevisedDraftTransdermalGel, Metered2230911/2013
Testosterone (PDF - 26KB) 10 mg/0.5 gm gelDraftTransdermalGel, Metered214634/2013
Testosterone (PDF - 27KB)1%RevisedDraftTransdermalGel2101511/2013
Testosterone (PDF - 27KB) 1%DraftTransdermalGel214544/2013
Testosterone (PDF - 27KB) 1.62%RevisedDraftTransdermalGel2230911/2013
Testosterone (PDF - 21KB)DraftTransdermalSolution, Metered225044/2013
Testosterone (PDF - 172KB) RevisedDraftTransdermalFilm, Extended Release0204894/2016
 Tetrabenazine (PDF - 46KB) Draft OralTablet21894 6/2012
Testosterone (PDF - 41KB)DraftImplantation Pellet809118/2011
Testosterone (PDF - 77KB)FinalOralTablet, Extended Release, Buccal215435/2008
Tetracycline HCl (PDF - 16KB)DraftOralCapsule607042/2010
Thalidomide (PDF -20KB)RevisedDraftOralCapsule

20785

21430

12/2012
Theophylline (PDF - 30KB)DraftOralTablet, Extended Release

40086 

87571

2/2010
Theophylline (PDF - 33KB)DraftOralTablet, Extended Release

81236 

89763 

89808

89807

2/2010
Theophylline (PDF - 18KB)RevisedDraftOralCapsule, Extended Release

87942 

87943 

87944

81034

9/2012
Thioguanine (PDF - 18KB)DraftOralTablet0124299/2012
Tiagabine HCl (PDF - 39KB) RevisedDraftOralTablet206466/2015

 Ticagrelor (PDF - 41KB) Revised

DraftOralTablet0224334/2016
Ticlopidine HCl (PDF - 46KB)FinalOralTablet199795/2008

 Timolol Maleate (PDF - 22KB)

DraftOralTablet0726686/2013
Tinidazole (PDF - 26KB)RevisedDraftOralTablet2161812/2012
Tioconazole (PDF - 165KB)DraftVaginalOintment206763/2011
Tipranavir (PDF - 39KB)DraftOralCapsule2181411/2007
Tizanidine HCl (PDF - 38KB)DraftOralTablets2039711/2010
Tizanidine HCl (PDF - 48KB)FinalOralCapsule214475/2008
Tofacitinib citrate (PDF - 22KB)DraftOralTablet20321412/2014

 Tolcapone (PDF - 39KB)

DraftOralTablet0206976/2015
Tolterodine Tartrate (PDF - 52KB)FinalOralTablet207715/2008
Tolterodine Tartrate (PDF - 19KB)RevisedDraftOralCapsules, Extended Release212289/2012
Tolvaptan (PDF - 19KB)DraftOralTablet222753/2012

Topiramate (PDF - 27KB) 

DraftOralCapsule, Extended Release2051223/2015

Topiramate  (PDF - 25KB) 

DraftOralCapsule, Extended Release2016353/2015
Topiramate (PDF - 35KB)
Revised
DraftOralTablet205056/2013
Topiramate (PDF - 17KB)
Revised
DraftOralCapsule, Sprinkle208446/2013
Topotecan HCl (PDF - 53 KB)DraftOralCapsule209813/2011
Toremifene Citrate (PDF - 30KB)FinalOralTablet2049710/2011
Torsemide (PDF - 50KB)FinalOralTablet201365/2008

 Tramadol HCl (PDF - 43KB)

DraftOralCapsule, Extended Release223709/2015
Tramadol HCl (PDF - 41KB)FinalOralTablet202815/2008
Tramadol HCl (PDF - 43KB)DraftOralTablet, Extended Release2169211/2007

 Trametinib dimethyl sulfoxide (PDF - 40KB)

DraftOralTablet2041141/2016
Trandolapril (PDF - 49KB)FinalOralTablet205285/2008
Trandolapril; Verapamil HC (PDF - 18KB)lDraftOralTablet, Extended Release2059112/2008
Tranexamic Acid (PDF - 32KB) RevisedDraftOralTablet224303/2011
Tranylcypromine Sulfate (PDF - 24KB)DraftOralTablet123424/2014
Trazodone HCl (PDF - 50KB)RevisedDraftOralTablet, Extended Release224119/2012
Trazodone HCl (PDF - 39KB)DraftOralTablet

71196 

71258

2/2010
Treprostinil diolamine (PDF - 41KB)DraftOralTablet, Extended Release20349612/2014

 

Tretinoin (PDF -135KB) (NDA 019963)

DraftTopicalCream199639/2012
Tretinoin (PDF -132KB) (NDA 021108)DraftTopicalCream211089/2012
Tretinoin (PDF -133KB) (NDA 020475)DraftTopicalGel (0.1%)204759/2012
Tretinoin (PDF -133KB) (NDA 020475)DraftTopicalGel (0.04%)204759/2012
Tretinoin (PDF - 117KB)DraftTopicalCream173403/2012
Tretinoin (PDF - 117KB)DraftTopicalCream175223/2012
Tretinoin (PDF - 117KB)DraftTopicalCream190493/2012
Tretinoin (PDF - 117KB)DraftTopicalCream900983/2012
Tretinoin (PDF - 116KB)DraftTopicalGel175793/2012
Tretinoin (PDF - 126KB)DraftTopicalGel179553/2012
Tretinoin (PDF - 126KB)DraftTopicalGel220703/2012
Tretinoin (PDF - 129KB)DraftTopicalSolution169213/2012
Tretinoin (PDF - 36KB)DraftOralCapsule776849/2010
Triamcinolone Acetonide (PDF - 29KB)DraftDentalPaste707303/2011
Triamcinolone Acetonide (PDF - 36KB) RevisedDraftInjectableSuspension

12041 

14901

2/2011
Triamterene (PDF - 40KB)FinalOralCapsule131745/2008
Triazolam (PDF - 33KB)DraftOralTablet178928/2010

 Trientine HCl (PDF - 22KB)

DraftOralCapsule0191946/2013
Trimethoprim (PDF - 17KB)DraftOralTablet

18679

2/2010

 Trimipramine maleate (PDF - 39KB)

DraftOralCapsule0167929/2015
Triptorelin Pamoate (PDF - 15KB) RevisedDraftIntramuscularInjectable

20715

21288

2/2014
Trospium Chloride (PDF - 23KB)DraftOralCapsule, Extended Release221038/2008
Trospium Chloride (PDF - 36KB)DraftOralTablet2159511/2007

 

Page Last Updated: 04/22/2016
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