Active Ingredient (link to Specific Guidance) | Type | Route of Administration | Dosage Form | RLD Application Number (link to Orange Book) | Date Recommended |
|---|
| Bacitracin (PDF - 25KB) | Draft | Ophthalmic | Ointment | 61212 | 6/2012 |
| Baclofen (PDF - 15KB) | Draft | Oral | Tablet, Orally Disintegrating | 21589 | 7/2008 |
| Baclofen (PDF - 26KB) | Draft | Oral | Tablet | 72235 72234 | 2/2010 |
| Balsalazide Disodium (PDF - 25KB) | Draft | Oral | Capsule | 20610 | 1/2008 |
Benazepril HCl (PDF - 43KB) | Draft | Oral | Tablet | 19851 | 7/2010 |
| Benzonatate (PDF - 39KB) | Final | Oral | Capsule | 11210 | 5/2008 |
| Benzoyl Peroxide; Clindamycin Phosphate (PDF - 257KB) | Draft | Topical | Gel | 50819 | 1/2011 |
| Benzoyl Peroxide; Clindamycin Phosphate (PDF - 325 KB) Revised | Draft | Topical | Gel | 50741 | 3/2012 |
| Benzoyl Peroxide; Clindamycin Phosphate (PDF - 271KB) Revised | Draft | Topical | Gel | 50756 | 3/2012 |
| Benzoyl Peroxide; Erythromycin (PDF - 212KB) Revised | Draft | Topical | Gel | 50557 | 9/2011 |
| Benzoyl Peroxide; Erythromycin (PDF - 212KB) Revised | Draft | Topical | Gel | 50769 | 9/2011 |
| Benzphetamine HCl (PDF - 46KB) | Final | Oral | Capsule | 12427 | 5/2008 |
| Betamethasone Acetate; Betamethasone Sodium Phosphate (PDF - 15KB) | Draft | Injection | Suspension, Injectable | 14602 | 4/2010 |
| Betamethasone Dipropionate; Calcipotriene Hydrate (PDF - 244KB) | Draft | Topical | Ointment | 21852 | 3/2011 |
| Betamethasone Dipropionate; Calcipotriene Hydrate (PDF - 261KB) | Draft | Topical | Suspension | 22185 | 3/2011 |
| Betamethasone Dipropionate; Clotrimazole (PDF - 41KB) | Draft | Topical | Lotion | 20010 | 3/2010 |
| Betamethasone Dipropionate; Clotrimazole (PDF - 38KB) | Draft | Topical | Cream | 18827 | 3/2010 |
| Bethanechol Chloride (PDF - 15KB) | Draft | Oral | Tablet | 88440 88441 89096 89095 | 9/2008 |
| Bexarotene (PDF - 46KB) | Draft | Oral | Capsule | 21055 | 9/2010 |
| Bicalutamide (PDF - 281KB) | Final | Oral | Tablet | 20498 | 5/2008 |
| Bismuth Subcitrate Potassium; Metronidazole; Tetracycline HCl (PDF - 16KB)l | Draft | Oral | Capsule | 50786 | 9/2008 |
| Bisoprolol Fumarate (PDF - 49KB) | Final | Oral | Tablet | 19982 | 5/2008 |
| Bisoprolol Fumarate; Hydrochlorothiazide (PDF - 119KB) | Final | Oral | Tablet | 20186 | 5/2008 |
| Boceprevir (PDF - 34KB) | Draft | Oral | Capsule | 202258 | 6/2012 |
| Bosentan (PDF - 34KB)Revised | Draft | Oral | Tablet | 21290 | 3/2012 |
| Brimonidine Tartrate (PDF - 14KB) | Draft | Ophthalmic | Solution/Drops | 21770 21262 76260 | 9/2008 |
| Bromfenac Sodium (PDF - 19KB) | Draft | Ophthalmic | Solution/Drops | 21664 | 3/2009 |
| Bromocriptine Mesylate (PDF - 15KB) | Draft | Oral | Capsule | 17962 | |
| Bromocriptine Mesylate (PDF - 15KB) | Draft | Oral | Tablet | 17962 | 11/2009 |
| Budesonide (PDF - 270KB) | Draft | Inhalation | Suspension | 20929 | 9/2012 |
| Budesonide (PDF - 16KB) | Draft | Oral | Capsule | 21324 | 10/2009 |
| Bumetanide (PDF - 15KB) | Draft | Oral | Tablet | 74700 | 7/2008 |
| Buprenorphine HCl (PDF - 36KB) | Draft | Oral | Tablet, Sublingual | 78633 | 5/2010 |
| Buprenorphine HCl; Naloxone HCl (PDF - 40KB) | Draft | Oral | Tablet, Sublingual | 20733 | 5/2010 |
Bupropion HBr (PDF - 21KB) Revised | Draft | Oral | Tablet, Extended Release | 22108 | 3/2013 |
| Bupropion HCl (PDF - 34KB)Revised | Draft | Oral | Tablet | 18644 | 3/2013 |
Bupropion HCl (PDF - 22KB) | Draft | Oral | Tablet, Extended Release | 21515 | 3/2013 |
| Bupropion HCl (PDF - 34KB)Revised | Draft | Oral | Tablet, Extended-Release | 20358 20711 | 3/2013 |
| Bupropion HCl (PDF - 34KB) | Draft | Oral | Tablet, Extended-Release | 22497 | 3/2013 |
| Buspirone (PDF - 19KB) | Draft | Oral | Tablet | 75022 | 12/2009 |
Busulfan (PDF - 16KB) Revised | Draft | Oral | Tablet | 09386 | 7/2009 |
| Butenafine HCl (PDF - 167KB) | Draft | Topical | Cream | 20524 | 3/2012 |
| Butenafine HCl (PDF - 168KB) | Draft | Topical | Cream | 21307 | 3/2012 |
| Butenafine HCl (PDF - 155KB) | Draft | Topical | Cream | 21408 | 3/2012 |
| Butoconazole Nitrate (PDF - 168 KB) | Draft | Vaginal | Cream | 200923 | 3/2011 |
| Butoconazole Nitrate (PDF - 179 KB) | Draft | Vaginal | Cream | 20421 | 3/2011 |