Active Ingredient
(link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number
(link to Orange Book) | Date
Recommended |
|---|
| Tacrolimus (PDF - 80KB) | Draft | Topical | Ointment 0.1% | 50777 | 3/2012 |
| Tacrolimus (PDF - 77KB) | Draft | Topical | Ointment 0.03% | 50777 | 3/2012 |
| 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) | Draft | Oral | Tablet | 21356 | 11/2007 |
| Terazosin HCl (PDF - 45KB) | Final | Oral | Capsule | 20347 | 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 |
| 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 |
| 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 | Tablet, Extended Release | 21228 | 9/2012 |
| Tolvaptan (PDF - 19KB) | Draft | Oral | Tablet | 22275 | 3/2012 |
Topiramate (PDF - 35KB)
Revised | Draft | Oral | Tablet | 20505 | 11/2010 |
Topiramate (PDF - 17KB)
Revised | Draft | Oral | Capsule, Sprinkle | 20844 | 9/2012 |
| 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 |
| 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 |
| Trimethoprim (PDF - 17KB) | Draft | Oral | Tablet | 71259 18679 | 2/2010 |
| Triptorelin Pamoate (PDF - 15KB) | Draft | Intramuscular | Injectable | 20715 21288 | 7/2008 |
| Trospium Chloride (PDF - 23KB) | Draft | Oral | Capsule, Extended Release | 22103 | 8/2008 |
| Trospium Chloride (PDF - 36KB) | Draft | Oral | Tablet | 21595 | 11/2007 |
