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U.S. Department of Health and Human Services

Drugs

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'B'

 

 

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)
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 - 67KB) 

 Draft  Oral  Tablet 022205 6/2013
Balsalazide Disodium (PDF - 25KB) Draft Oral Capsule 20610 1/2008

 

Bedaquiline Fumarate (PDF - 25KB)

 Draft  Oral Tablet 204384 11/2013

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 - 86KB) Draft Ophthalmic Solution/Drops 0.1%

21770

2/2014
Brimonidine Tartrate (PDF - 87KB) Draft Ophthalmic Solution/Drops 0.2%

76260

2/2014
Brimonidine Tartrate (PDF - 87KB) Draft Ophthalmic Solution/Drops 0.15%

21262

2/2014
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)Revised Draft Oral Tablet 74700 11/2013
Buprenorphine HCl (PDF - 36KB) Revised Draft Oral Tablet, Sublingual 78633 2/2014
Buprenorphine HCl; Naloxone HCl (PDF - 40KB) Draft Oral Tablet, Sublingual 91422 5/2010
Bupropion HBr (PDF - 21KB)
Revised
Draft Oral Tablet, Extended Release 22108 3/2013
Bupropion HCl (PDF - 34KB) Draft Oral Tablet, Extended-Release 22497 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
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