Active Ingredient
(link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number
(link to Orange Book) | Date
Recommended |
|---|
| Econazole Nitrate (PDF - 78KB) | Draft | Topical | Cream | 76075 | 3/2010 |
| Efavirenz (PDF - 38KB) | Final | Oral | Capsule | 20972 | 5/2008 |
| Efavirenz (PDF - 45KB) | Final | Oral | Tablet | 21360 | 5/2008 |
| Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate (PDF - 16KB) | Draft | Oral | Tablet | 21937 | 10/2008 |
| Eletriptan Hydrobromide (PDF - 33KB) | Final | Oral | Tablet | 21016 | 10/2011 |
| Emtricitabine (PDF - 38KB) Revised | Final | Oral | Capsule | 21500 | 8/2010 |
| Enalapril Maleate (PDF - 22KB) | Draft | Oral | Tablet | 18998 | 8/2008 |
| Enoxaparin Sodium (PDF - 42KB) | Draft | Subcutaneous | Injection | 20164 | 10/2011 |
| Entacapone (PDF - 52KB) | Final | Oral | Tablet | 20796 | 5/2008 |
| Entecavir (PDF - 41KB) | Final | Oral | Tablet | 21797 | 5/2008 |
| Eplerenone (PDF - 54KB) | Final | Oral | Tablet | 21437 | 5/2008 |
| Eprosartan Mesylate (PDF - 16KB) | Draft | Oral | Tablet | 20738 | 7/2008 |
| Eprosartan Mesylate; Hydrochlorothiazide (PDF - 57KB) | Draft | Oral | Tablet | 21268 | 2/2008 |
Ergocalciferol (PDF - 46KB) | Draft | Oral | Capsule | 03444 | 11/2010 |
| Erlotinib HCl (PDF - 16KB) | Final | Oral | Tablet | 21743 | 2/2008 |
| Erythromycin (PDF - 28KB) | Draft | Opthalmic | Ointment | 62447 | 6/2012 |
| Erythromycin (PDF - 14KB) | Draft | Topical | Solution | 64187 | 2/2010 |
| Erythromycin (PDF - 12KB) | Draft | Topical | Swab | 64126 | 2/2010 |
| Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl (PDF - 34KB) | Draft | Oral | Granule | 62759 | 5/2010 |
| Escitalopram Oxalate (PDF - 16KB) | Draft | Oral | Capsule | 77660 | 9/2008 |
| Escitalopram Oxalate (PDF - 45KB) | Final | Oral | Tablet | 21323 | 5/2008 |
| Esomeprazole Magnesium (PDF - 18KB) | Draft | Oral | Powder, Delayed Release | 21957 22101 | 2/2010 |
| Esomeprazole Magnesium (PDF - 55KB) Revised | Final | Oral | Capsule, Delayed Release Pellets | 21153 | 3/2011 |
| Esomeprazole Magnesium; Naproxen (PDF - 45KB) | Draft | Oral | Tablets, Delayed Release | 22511 | 3/2011 |
| Estradiol (PDF - 33KB) | Draft | Oral | Tablet | 84500 84499 81295 | 12/2010 |
| Estradiol (PDF - 466KB) | Draft | Transdermal | Film, Extended Release | 19081 | 11/2010 |
| Estradiol (PDF - 405KB) | Draft | Transdermal | Film, Extended Release | 20375 21674 | 11/2010 |
| Estradiol (PDF - 437KB) | Draft | Transdermal | Film, Extended Release | 20538 | 11/2010 |
| Estradiol (PDF - 68KB) | Draft | Vaginal | Cream | 86069 | 8/2009 |
| Estradiol (PDF - 69KB) Revised | Draft | Vaginal | Tablet | 20908 | 3/2011 |
| Estrogens, Conjugated Synthetic A (PDF - 17KB) | Draft | Oral | Tablet | 20992 | 4/2010 |
| Estrogens, Esterified (PDF - 19KB)Revised | Draft | Oral | Tablet | 84948
84949
84950
84951
| 9/2012 |
| Eszopiclone (PDF - 18KB) | Draft | Oral | Tablet | 21476 | 1/2008 |
| Ethacrynic Acid (PDF - 32KB) | Draft | Oral | Tablet | 16092 | 12/2010 |
| Ethambutol HCl (PDF - 18KB) | Draft | Oral | Tablet | 75095 | 1/2008 |
Ethinyl Estradiol; Ethynodiol Diacetate (PDF - 20KB)
Revised | Draft | Oral | Tablet | 72723 72721 | 12/2009 |
| Ethinyl Estradiol; Levonorgestrel (PDF - 18KB) | Draft | Oral | Tablet | 74538 | 11/2009 |
| Ethinyl Estradiol; Levonorgestrel(PDF - 20KB) | Draft | Oral | Tablet | 21544 22262 21840 | 11/2009 |
| Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) | Draft | Oral | Tablet | 21864 | 4/2009 |
| Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) | Draft | Oral | Tablet | 18782 | 3/2009 |
| Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) | Draft | Oral | Tablet | 76625 | 3/2009 |
| Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) | Draft | Oral | Tablet | 77681 | 10/2008 |
| Ethinyl Estradiol; Norelgestromin (PDF - 130KB) | Draft | Transdermal | Film, Extended Release | 21180 | 5/2009 |
| Ethinyl Estradiol; Norethindrone (PDF - 41KB) | Draft | Oral | Tablet, Chewable | 22573 | 3/2012 |
| Ethinyl Estradiol; Norethindrone (PDF - 30KB) | Draft | Oral | Tablet | 17716 17576 | 2/2010 |
| Ethinyl Estradiol; Norethindrone (PDF - 16KB) | Draft | Oral | Tablet | 18977 | 11/2009 |
| Ethinyl Estradiol; Norethindrone (PDF - 22KB) Revised | Draft | Oral | Tablet, Chewable | 21490 | 7/2010 |
Ethinyl Estradiol; Norethindrone (PDF - 43KB)
Revised | Draft | Oral | Tablet | 18985 17735 17919 | 12/2010 |
| Ethinyl Estradiol; Norethindrone Acetate (PDF - 39KB) | Draft | Oral | Tablet | 22501 | 6/2011 |
| Ethinyl Estradiol; Norethindrone Acetate (PDF - 18KB) | Draft | Oral | Tablet | 17355 17875 17354 17876 21871 | 10/2009 |
| Ethinyl Estradiol; Norethindrone Acetate (PDF - 23KB) | Draft | Oral | Tablet | 20907 | 3/2009 |
| Ethinyl Estradiol; Norethindrone Acetate (PDF - 16KB) | Draft | Oral | Tablet | 20130 | 7/2008 |
| Ethinyl Estradiol; Norethindrone Acetate (PDF - 16KB) | Draft | Oral | Tablet | 21065 | 7/2008 |
| Ethinyl Estradiol; Norgestimate (PDF - 21 KB) | Draft | Oral | Tablet | 19653 19697 21241 | 12/2009 |
| Ethinyl Estradiol; Norgestrel (PDF - 20KB) | Draft | Oral | Tablet | 75406 75288 | 10/2009 |
| Ethosuximide (PDF - 15KB) | Draft | Oral | Capsule | 12380 | 7/2008 |
| Etidronate Disodium (PDF - 45KB) | Final | Oral | Tablet | 17831 | 5/2008 |
| Etodolac (PDF - 34KB) | Draft | Oral | Tablet, Extended Release | 75665 | 7/2010 |
| Etoposide (PDF - 41KB) | Draft | Oral | Capsule | 75635 | 8/2010 |
| Etravirine (PDF - 34KB) Revised | Draft | Oral | Tablet | 22187 | 9/2012 |
| Everolimus (PDF - 34KB)Revised | Draft | Tablets | Oral | 22334 | 6/2012 |
| Exemestane (PDF - 46KB) | Final | Oral | Tablet | 20753 | 5/2008 |
| Ezetimibe (PDF - 16KB) | Draft | Oral | Tablet | 21445 | 10/2008 |
| Ezetimibe; Simvastatin (PDF - 17KB) | Draft | Oral | Tablet | 21687 | 9/2008 |
