Drugs

Product-Specific Recommendations for Generic Drug Development: 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
 Bacitracin (PDF - 25KB) Draft OphthalmicOintment61212  6/2012
Baclofen (PDF - 15KB)DraftOralTablet, Orally Disintegrating215897/2008
Baclofen (PDF - 26KB)DraftOralTablet

72235 

72234

2/2010

 Balsalazide Disodium (PDF - 67KB) 

 Draft Oral Tablet0222056/2013
Balsalazide Disodium (PDF - 25KB)DraftOralCapsule206101/2008

 

Bedaquiline Fumarate (PDF - 25KB)

 Draft OralTablet20438411/2013

Benazepril HCl (PDF - 43KB)

DraftOralTablet198517/2010
Benzonatate (PDF - 39KB)FinalOralCapsule112105/2008
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 257KB)DraftTopicalGel508191/2011
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 325 KB) RevisedDraftTopicalGel507413/2012
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 271KB) RevisedDraftTopicalGel507563/2012
Benzoyl Peroxide; Erythromycin (PDF - 212KB) RevisedDraftTopicalGel505579/2011
Benzoyl Peroxide; Erythromycin (PDF - 212KB) RevisedDraftTopicalGel507699/2011
Benzyl alcohol (PDF - 135KB)DraftTopicalLotion02212912/2014
Benzphetamine HCl (PDF - 46KB)FinalOralCapsule124275/2008
Betamethasone Acetate; Betamethasone Sodium Phosphate (PDF - 15KB)DraftInjectionSuspension, Injectable146024/2010
Betamethasone Dipropionate; Calcipotriene Hydrate (PDF - 244KB)DraftTopicalOintment218523/2011
Betamethasone Dipropionate; Calcipotriene Hydrate (PDF - 261KB)DraftTopicalSuspension221853/2011
Betamethasone Dipropionate; Clotrimazole (PDF - 41KB)DraftTopicalLotion200103/2010
Betamethasone Dipropionate; Clotrimazole (PDF - 38KB)DraftTopicalCream188273/2010
Betamethasone valerate (PDF - 45KB)DraftTopicalFoam, aerosol

20934

12/2014
Bethanechol Chloride (PDF - 15KB)DraftOralTablet

88440 

88441

89096

89095
 

9/2008
Bexarotene (PDF - 46KB)DraftOralCapsule210559/2010
Bicalutamide (PDF - 281KB)FinalOralTablet204985/2008
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline HCl (PDF - 16KB)lDraftOralCapsule507869/2008
Bisoprolol Fumarate (PDF - 49KB)FinalOralTablet199825/2008
Bisoprolol Fumarate; Hydrochlorothiazide (PDF - 119KB)FinalOralTablet201865/2008
 Boceprevir (PDF - 34KB) Draft OralCapsule202258  6/2012
Bosentan (PDF - 34KB)RevisedDraftOralTablet212903/2012
Bosutinib monohydrate (PDF - 21KB)DraftOralTablet

203341

12/2014
Brimonidine Tartrate (PDF - 86KB) RevisedDraftOphthalmicSolution/Drops 0.1%

21770

3/2015
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops 0.2%

76260

3/2015
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops 0.15%

21262

3/2015
Brimonidine tartrate; Brinzolamide (PDF - 85KB)RevisedDraft OphthalmicDrops, Suspension2042513/2015

Brinzolamide (PDF - 85KB) Revised

DraftOphthalmicSuspension/Drops 1%

20816

3/2015
Bromfenac Sodium (PDF - 19KB)DraftOphthalmicSolution/Drops216643/2009
Bromocriptine Mesylate (PDF - 15KB)DraftOralCapsule17962 
Bromocriptine Mesylate (PDF - 15KB)DraftOralTablet1796211/2009

Budesonide (PDF - 39KB)

DraftOralCapsule

21324

3/2015
Budesonide (PDF - 270KB)DraftInhalationSuspension209299/2012
Budesonide (PDF - 39KB)DraftOralTablet, Extended release

203634

12/2014
Bumetanide (PDF - 15KB)RevisedDraftOralTablet7470011/2013

Buprenorphine (PDF - 145KB)

DraftTransdermalFilm, Extended Release

21306

4/2014
Buprenorphine HCl (PDF - 36KB) RevisedDraftOralTablet, Sublingual786332/2014

 Buprenorphine HCl; Naloxone HCl (PDF -60KB)

 Draft BuccalFilm2056373/2015

Buprenorphine HCl; Naloxone HCl (PDF - 26KB)

Draft SublingualFilm0224104/2014
Buprenorphine HCl; Naloxone HCl (PDF - 40KB)DraftOralTablet, Sublingual914225/2010
Buprenorphine HCl; Naloxone HCl (PDF - 23KB) 

 

DraftOralTablet, Sublingual20424212/2014
Bupropion HBr (PDF - 21KB)
Revised
DraftOralTablet, Extended Release221083/2013
Bupropion HCl (PDF - 34KB)DraftOralTablet, Extended-Release224973/2013
Bupropion HCl (PDF - 34KB)RevisedDraftOralTablet186443/2013
Bupropion HCl (PDF - 22KB)
 
DraftOralTablet, Extended Release215153/2013
Bupropion HCl (PDF - 34KB)RevisedDraftOralTablet, Extended-Release

20358

20711

3/2013
Buspirone (PDF - 19KB)DraftOralTablet7502212/2009
Busulfan (PDF - 16KB)
Revised
DraftOralTablet093867/2009
Butenafine HCl (PDF - 167KB) Draft TopicalCream20524 3/2012
Butenafine HCl (PDF - 168KB) Draft TopicalCream21307 3/2012
Butoconazole Nitrate (PDF - 168 KB)DraftVaginalCream2009233/2011
Butoconazole Nitrate (PDF - 179 KB)DraftVaginalCream204213/2011

 

Page Last Updated: 06/15/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.