Active Ingredient
(link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number
(link to Orange Book) | Date
Recommended |
|---|
| Calcipotriene (PDF - 277KB) | Draft | Topical | Foam | 22563 | 1/2011 |
| Calcipotriene (PDF - 295KB) | Draft | Topical | Cream | 20554 | 8/2010 |
| Calcipotriene (PDF - 54KB) Revised | Draft | Topical | Ointment | 90633 | 9/2010 |
| Calcipotriene (PDF - 31KB) | Draft | Topical | Solution | 20611 | 8/2010 |
| Calcitonin-Salmon (PDF - 21KB) | Draft | Nasal | Spray, Metered | 20313 | 9/2012 |
| Calcitriol (PDF - 43KB) Revised | Draft | Oral | Capsule | 18044 | 9/2010 |
| Calcium Acetate (PDF - 16KB)Revised | Draft | Oral | Tablet | 78502 | 6/2011 |
| Calcium Acetate (PDF - 16KB)Revised | Draft | Oral | Capsule | 21160 | 6/2011 |
| Candesartan Cilexetil (PDF - 56KB) | Final | Oral | Tablet | 20838 | 5/2008 |
Candesartan Cilexetil; Hydrochlorothiazide (PDF - 15KB)
Revised | Draft | Oral | Tablet | 21093 | 9/2008 |
| Capecitabine (PDF - 46KB) Revised | Draft | Oral | Tablet | 20896 | 9/2012 |
| Carbamazepine (PDF - 35KB) | Draft | Oral | Tablet | 16608 | 8/2011 |
| Carbamazepine (PDF - 19KB) | Draft | Oral | Tablet, Extended Release | 20234 | 2/2008 |
| Carbamazepine (PDF - 42KB) | Draft | Oral | Capsule, Extended Release | 20712 | 11/2007 |
| Carbamazepine(PDF - 42KB) | Final | Oral | Suspension | 18927 | 5/2008 |
Carbidopa; Entacapone; Levodopa (PDF - 16KB)
Revised | Draft | Oral | Tablet | 21485 | 7/2009 |
| Carbidopa; Levodopa (PDF - 19KB) | Draft | Oral | Tablet, Extended Release | 19856 | 9/2012 |
| Carbidopa; Levodopa (PDF - 16KB) | Draft | Oral | Tablet, Orally Disintegrating | 76699 | 2/2010 |
| Carglumic Acid (PDF - 17KB) | Draft | Oral | Tablet | 22562 | 9/2012 |
| Carisoprodol (PDF - 18KB) | Draft | Oral | Tablet | 11792 | 3/2010 |
| Carvedilol (PDF - 49KB) | Final | Oral | Tablet | 20297 | 5/2008 |
| Carvedilol Phosphate (PDF - 30KB) | Draft | Oral | Capsule, Extended Release | 22012 | 2/2010 |
| Cefaclor (PDF - 34KB) | Draft | Oral | Capsule | 65350 | 2/2011 |
| Cefadroxil; Cefadroxil Hemihydrate (PDF - 36KB) | Draft | Oral | Capsule | 65282 | 9/2010 |
| Cefdinir (PDF - 18KB) Revised | Draft | Oral | Capsule | 65330 | 9/2010 |
| Cefditoren Pivoxil (PDF - 18KB) | Draft | Oral | Tablet | 21222 | 3/2010 |
| Cefditoren Pivoxil (PDF - 16KB) Revised | Final | Oral | Tablet | 21222 | 2/2010 |
| Cefixime (PDF - 32KB) | Draft | Oral | Tablet | 65130 | 2/2011 |
| Cefixime (PDF - 18KB)Revised | Draft | Oral | Suspension | 65129 65355 202091 | 4/2013 |
| Cefpodoxime Proxetil (PDF - 41KB) | Draft | Oral | Suspension | 65409 | 6/2012 |
| Cefpodoxime Proxetil (PDF - 41KB) | Draft | Oral | Tablet | 65462 | 6/2012 |
| Cefprozil (PDF - 40KB) | Draft | Oral | Suspension | 65261 | 6/2012 |
| Cefprozil (PDF - 39KB) | Draft | Oral | Tablet | 65276 | 6/2012 |
| Cefuroxime Axetil (PDF - 33KB) | Draft | Oral | Tablet | 50605 | 8/2010 |
| Cefuroxime Axetil (PDF - 16KB) | Draft | Oral | Suspension | 50672 | 2/2010 |
| Celecoxib (PDF - 32KB) | Draft | Oral | Capsule | 20998 | 5/2007 |
| Cetirizine HCl(PDF - 46KB) | Final | Oral | Tablet, Chewable | 21621 | 5/2008 |
| Cephalexin (PDF - 33KB) | Final | Oral | Capsule | 50405 | 10/2011 |
| Cetirizine HCl (PDF - 41KB) | Draft | Oral | Tablet, Orally Disintegrating | 22578 | 6/2012 |
| Cetirizine Hydrochloride (PDF - 34KB) | Draft | Oral | Capsule | 22429 | 4/2011 |
| Cetirizine HCl; Pseudoephedrine HCl (PDF - 60KB) | Draft | Oral | Tablet, Extended Release | 21150 | 2/2008 |
| Cevimeline HCl (PDF - 48KB) | Final | Oral | Capsule | 20989 | 5/2008 |
| Chlorambucil (PDF - 44KB) | Draft | Oral | Tablet | 10669 | 7/2010 |
| Chlorpheniramine Polistirex; Hydrocodone Polistirex (PDF - 18KB) | Draft | Oral | Suspension | 19111 | 2/2010 |
| Chlorpheniramine Polistirex; Hydrocodone Polistirex (PDF - 19KB) | Draft | Oral | Capsule, Extended Release | 77273 | 12/2008 |
| Chlorpromazine HCl (PDF - 45KB) | Draft | Oral | Tablet | 80439 | 3/2012 |
| Chlorthalidone (PDF - 36 KB) | Draft | Oral | Tablet | 86831 87180 19574 | 12/2009 |
| Cholestyramine (PDF - 168KB) Revised | Draft | Oral | Powder | 74557 74558 | 3/2012 |
| Choline Fenofibrate (PDF - 39KB) | Draft | Oral | Capsule, Delayed Release | 22224 | 12/2010 |
| Ciclesonide (PDF - 25KB) | Draft | Nasal | Aerosol, Metered | 202129 | 9/2012 |
| Ciclopirox (PDF - 37KB) | Draft | Topical | Suspension | 19824 | 3/2010 |
| Ciclopirox (PDF - 107KB) | Draft | Topical | Cream | 18748 | 2/2010 |
| Ciclopirox (PDF - 80KB) | Draft | Topical | Gel | 20519 | 2/2010 |
| Ciclopirox (PDF - 25KB) | Draft | Topical | Shampoo | 21159 | 2/2010 |
| Ciclopirox (PDF - 22KB) Revised | Draft | Topical | Solution | 21022 | 2/2011 |
| Cilostazol (PDF - 57KB) | Final | Oral | Tablet | 20863 | 5/2008 |
| Cinacalcet HCl (PDF - 47KB) | Final | Oral | Tablet | 21688 | 5/2008 |
| Ciprofloxacin (PDF - 33KB) | Final | Oral | Suspension | 20780 | 10/2011 |
| Ciprofloxacin; Dexamethasone (PDF - 149KB | Draft | Otic | Suspension/Drops | 21537 | 9/2012 |
| Ciprofloxacin HCl; Hydrocortisone (PDF - 239KB) | Draft | Otic | Suspension/Drops | 20805 | 6/2012 |
| Ciprofloxacin HCl (PDF - 31KB) | Draft | Ophthalmic | Drops, Solution | 19992 | 6/2011 |
| Ciprofloxacin HCl (PDF - 33KB) | Draft | Oral | Tablet | 19537 | 9/2010 |
| Ciprofloxacin HCl (PDF - 80KB) | Draft | Oral | Tablet, Extended Release | 21744 | 11/2007 |
| Ciprofloxacin; Ciprofloxacin HCl (PDF - 19KB) | Draft | Oral | Tablet, Extended Release | 21473 | 1/2008 |
| Citalopram HBr (PDF - 16KB) | Draft | Oral | Capsule | 77668 | 9/2008 |
| Citalopram HBr (PDF - 21KB) | Draft | Oral | Tablet | 20822 | 8/2008 |
| Clarithromycin (PDF - 15KB) | Draft | Oral | Tablet | 50662 | 2/2010 |
| Clarithromycin (PDF - 19KB) | Draft | Oral | Tablet, Extended Release | 50775 | 1/2008 |
| Clarithromycin (PDF - 45KB) | Final | Oral | Suspension | 50698 | 5/2008 |
| Clindamycin HCL (PDF -31KB) | Draft | Oral | Capsule | 50162 | 9/2011 |
| Clindamycin Phosphate (PDF -230KB) | Draft | Vaginal | Cream | 50680 | 3/2012 |
| Clindamycin Phosphate (PDF - 230KB) | Draft | Vaginal | Cream | 50793 | 3/2012 |
| Clindamycin Phosphate (PDF - 227KB) | Draft | Vaginal | Suppository | 50767 | 3/2012 |
| Clindamycin Phosphate (PDF - 43KB) | Draft | Topical | Foam, Aerosol | 50801 | 4/2011 |
| Clindamycin Phosphate (PDF - 243KB) | Draft | Topical | Gel | 50615 | 4/2011 |
| Clindamycin Phosphate (PDF - 225KB) | Draft | Topical | Gel | 50782 | 4/2011 |
| Clindamycin Phosphate (PDF - 231KB) | Draft | Topical | Lotion | 50600 | 4/2011 |
| Clindamycin Phosphate (PDF - 38KB) | Draft | Topical | Solution | 50537 | 4/2011 |
| Clindamycin Phosphate (PDF - 34KB) | Draft | Topical | Swab | 50537 | 4/2011 |
Clindamycin Phosphate; Tretinoin (PDF -138 KB) | Draft | Topical | Gel | 50802 50803 | 12/2012 |
| Clobetasol Propionate (PDF -46KB) | Draft | Topical | Foam, Aerosol | 21142 | 2/2011 |
| Clobetasol Propionate (PDF -33KB) | Draft | Topical | Shampoo | 21644 | 2/2011 |
| Clobetasol Propionate (PDF -27KB) | Draft | Topical | Spray | 21835 | 2/2011 |
| Clobetasol Propionate (PDF - 28KB) | Draft | Topical | Solution | 19966 | 8/2010 |
| Clomiphene Citrate (PDF - 33KB) | Draft | Oral | Tablet | 16131 | 6/2012 |
| Clonazepam (PDF - 16KB) | Draft | Oral | Tablet | 17533 | 4/2010 |
| Clonidine (PDF - 39KB) | Draft | Oral | Tablet, Extended Release | 22500 | 8/2010 |
|
| Clonidine (PDF - 126KB) | Draft | Transdermal | Film, Extended Relese | 18891 | 11/2009 |
| Clonidine HCl (PDF - 41KB) | Final | Oral | Tablet | 17407 | 5/2008 |
Clopidogrel Bisulfate (PDF - 21KB)
Revised | Draft | Oral | Tablet | 20839 | 8/2008 |
Clorazepate Dipotassium (PDF - 67KB) | Draft | Oral | Tablet | 17105 | 12/2012 |
| Clotrimazole (PDF - 164KB)Revised | Draft | Topical | Solution | 74580 | 6/2011 |
| Clotrimazole (PDF - 76KB) | Draft | Topical | Cream | 72640 | 3/2010 |
| Clotrimazole (PDF - 78KB) | Draft | Vaginal | Cream | 18052 | 10/2009 |
| Clotrimazole (PDF - 78KB) | Draft | Vaginal | Cream | 20574 | 10/2009 |
| Clotrimazole (PDF - 82KB) | Draft | Vaginal | Tablet | 17717 | 10/2009 |
| Clotrimazole (PDF - 81KB) | Draft | Vaginal | Tablet | 20525 | 10/2009 |
| Clotrimazole (PDF - 46KB) | Draft | Oral | Troche/Lozenge | 76387 | 9/2008 |
| Clozapine (PDF - 78 KB) | Final | Oral | Tablet | 19758 | 3/2011 |
| Colchicine (PDF - 33KB) | Draft | Oral | Tablet | 22352 | 9/2010 |
| Colesevelam HCl (PDF - 41KB)Revised | Draft | Oral | Powder, Suspension | 22362 | 3/2012 |
Colesevelam HCl (PDF - 18KB)
revised | Draft | Oral | Tablet | 21176 | 6/2011 |
| Cyclobenzaprine HCl (PDF - 25KB) | Draft | Oral | Tablet | 17821 | 2/2010 |
| Cyclobenzaprine HCl (PDF - 23KB) | Draft | Oral | Capsule, Extended Release | 21777 | 8/2008 |
| Cyclophosphamide (PDF -KB) | Draft | Oral | Tablet | 040032 | 9/2012 |
