Drugs

Product-Specific Guidances for Generic Drug Development: Active Ingredients starting with 'B'

 

 

Product-Specific Guidances 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 - 39KB) Revised  Draft  Ophthalmic Ointment 61212  10/2016
Baclofen (PDF - 15KB) Draft Oral Tablet, Orally Disintegrating 21589 7/2008
Baclofen (PDF - 26KB) Draft Oral Tablet

17851

2/2010

Balsalazide Disodium (PDF - 67KB) 

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

Beclomethasone dipropionate (PDF - 99KB)

 Draft  Inhalation Aerosol, metered 020911 1/2016

 

Bedaquiline Fumarate (PDF - 25KB)

 Draft  Oral Tablet 204384 11/2013

Benazepril HCl (PDF - 43KB)

Draft Oral Tablet 19851 7/2010

Benazepril HCl; Hydrochlorothiazide (PDF - 41KB)

Draft Oral Tablet 20033 9/2015
Benzonatate (PDF - 39KB) Revised Draft Oral Capsule 11210 9/2015
Benzoyl Peroxide; Clindamycin Phosphate (PDF - 257KB)   Revised Draft Topical Gel 50819 6/2016
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
Benzyl alcohol (PDF - 135KB) Draft Topical Lotion 022129 12/2014
Benzphetamine HCl (PDF - 46KB) Final Oral Tablet 12427 5/2008
Betamethasone Acetate; Betamethasone Sodium Phosphate (PDF - 15KB) Draft Injection Suspension, Injectable 14602 4/2010

Betamethasone dipropionate (PDF - 33KB)

 Draft Topical Cream 019137 10/2016

Betamethasone dipropionate  (PDF - 39KB)

 Draft Topical Cream, augmented 19555 4/2016

Betamethasone dipropionate (PDF - 40KB)

Draft Topical Lotion (augmented) 019716 1/2016
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

Betamethasone valerate (PDF - 35KB) 

 Draft Topical Cream 018861 12/2016

Betamethasone valerate (PDF - 31KB)

Draft Topical Ointment 18865 10/2016
Betamethasone valerate (PDF - 45KB) Draft Topical Foam, aerosol

20934

12/2014

Betamethasone valerate (PDF -39KB)

Draft Topical Lotion 018866 1/2016

Betaxolol hydrochloride (PDF - 91KB)

Draft Ophthalmic Suspension/drops 019845 1/2016
Bethanechol Chloride (PDF - 15KB) Draft Oral Tablet

006536 
 

9/2008
Bexarotene (PDF - 46KB) Revised Draft Oral Capsule 21055 5/2017
Bicalutamide (PDF - 281KB) Final Oral Tablet 20498 5/2008
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline HCl (PDF - 16KB)l Draft Oral Capsule 50786 9/2008

Bisacodyl; Polyethylene Glycol 3350; Potassium Chloride;  Sodium Bicarbonate; Sodium Chloride (PDF - 39KB)

Draft Oral Tablet, Delayed Release for Solution 021551 5/2017
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 021551   6/2012
Bosentan (PDF - 34KB)Revised Draft Oral Tablet 21290 3/2012
Bosutinib monohydrate (PDF - 21KB) Draft Oral Tablet

203341

12/2014

Brexpiprazole (PDF - 39KB)

 Draft Oral Tablet 205422 7/2017
Brimonidine Tartrate (PDF - 86KB) Revised Draft Ophthalmic Solution/Drops 0.1%

21770

8/2017
Brimonidine Tartrate (PDF - 87KB) Revised Draft Ophthalmic Solution/Drops 0.2%

20613

8/2017

Brimonidine tartrate (PDF - 114KB)

Draft Topical Gel 204708 9/2015
Brimonidine Tartrate (PDF - 87KB) Revised Draft Ophthalmic Solution/Drops 0.15%

21262

7/2017
Brimonidine tartrate; Brinzolamide (PDF - 85KB)Revised Draft  Ophthalmic Drops, Suspension 204251 3/2015

Brinzolamide (PDF - 85KB) Revised

Draft Ophthalmic Suspension/Drops 1%

20816

3/2015

Brivaracetam  (PDF - 41KB)

Draft Oral Tablet 205836 7/2017
Bromfenac Sodium (PDF - 19KB) Revised Draft Ophthalmic Solution/Drops 21664 8/2017
Bromocriptine Mesylate (PDF - 15KB) Draft Oral Capsule 17962 11/2009;
Bromocriptine Mesylate (PDF - 15KB) Draft Oral Tablet 17962 11/2009

Budesonide (PDF - 107KB)

Draft Inhalation Powder 21949 12/2016

Budesonide (PDF - 39KB)

Draft Oral Capsule

21324

3/2015
Budesonide (PDF - 270KB) Draft Inhalation Suspension 20929 9/2012
Budesonide (PDF - 39KB) Draft Oral Tablet, Extended release

203634

12/2014

Budesonide; Formoterol fumarate dihydrate (PDF - 100KB)

Draft Inhalation Aerosol, metered 021929 6/2015
Bumetanide (PDF - 15KB) Revised Draft Oral Tablet 18225 11/2013

Buprenorphine (PDF - 161KB) Revised

Draft Transdermal Film, Extended Release

21306

10/2016
Buprenorphine HCl (PDF - 36KB) Revised Draft Oral Tablet, Sublingual 020732 2/2014

Buprenorphine HCl; Naloxone HCl (PDF -60KB)

 Draft  Buccal Film 205637 3/2015

Buprenorphine HCl; Naloxone HCl (PDF - 26KB) Revised

Draft  Buccal, Sublingual Film 022410 12/2016
Buprenorphine HCl; Naloxone HCl (PDF - 40KB) Draft Oral Tablet, Sublingual 020733 5/2010
Buprenorphine HCl; Naloxone HCl (PDF - 23KB)  Revised  Draft Oral Tablet, Sublingual 204242 12/2016
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
 

Bupropion HCl; Naltrexone HCl (PDF - 46KB) 

Draft Oral Tablet, Extended Release 200063 9/2015
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
Butoconazole Nitrate (PDF - 168 KB) Draft Vaginal Cream 200923 3/2011
Butoconazole Nitrate (PDF - 179 KB) Draft Vaginal Cream 20421 3/2011

 

Page Last Updated: 09/20/2017
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