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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 C

 

 

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
Calcipotriene (PDF - 277KB) Draft Topical Foam 22563 1/2011
Calcipotriene (PDF - 295KB) Draft Topical Cream 20554 8/2010
Calcipotriene (PDF - 54KB) Revised Draft Topical Ointment 90633 9/2010
Calcipotriene (PDF - 31KB) Draft Topical Solution 77029 8/2010
Calcitonin-Salmon (PDF - 21KB) Draft  Nasal Spray, Metered 20313 9/2012
Calcitriol (PDF - 43KB) Revised Draft Oral Capsule 18044 9/2010
Calcium Acetate (PDF - 16KB)Revised Draft Oral Tablet 78502 6/2011
Calcium Acetate (PDF - 16KB)Revised Draft Oral Capsule 21160 6/2011
Candesartan Cilexetil (PDF - 56KB) Final Oral Tablet 20838 5/2008
Candesartan Cilexetil; Hydrochlorothiazide (PDF - 15KB)
Revised
Draft Oral Tablet 21093 9/2008
Capecitabine (PDF - 46KB) Revised Draft Oral Tablet 20896 9/2012
Carbamazepine (PDF - 35KB) Draft Oral Tablet 16608 8/2011
Carbamazepine (PDF - 19KB) Draft Oral Tablet, Extended Release 20234 2/2008
Carbamazepine (PDF - 42KB) Draft Oral Capsule, Extended Release 20712 11/2007
Carbamazepine(PDF - 42KB) Final Oral Suspension 18927 5/2008
Carbidopa; Entacapone; Levodopa (PDF - 16KB)
Revised
Draft Oral Tablet 21485 6/2013
Carbidopa; Levodopa (PDF - 19KB) Draft  Oral  Tablet, Extended Release 19856 9/2012
Carbidopa; Levodopa (PDF - 16KB) Draft Oral Tablet, Orally Disintegrating 76699 2/2010
Carglumic Acid (PDF - 17KB) Draft  Oral Tablet 22562 9/2012
Carisoprodol (PDF - 18KB) Draft Oral Tablet 11792 3/2010
Carvedilol (PDF - 49KB) Final Oral Tablet 20297 5/2008
Carvedilol Phosphate (PDF - 30KB) Draft Oral Capsule, Extended Release 22012 2/2010
Cefaclor (PDF - 34KB) Draft Oral Capsule 65350 2/2011
Cefadroxil; Cefadroxil Hemihydrate (PDF - 36KB) Draft Oral Capsule 65282 9/2010
Cefdinir (PDF - 18KB) Revised Draft Oral Capsule 65330 9/2010
Cefditoren Pivoxil (PDF - 18KB) Draft Oral Tablet 21222 3/2010
Cefditoren Pivoxil (PDF - 16KB) Revised Final Oral Tablet 21222 2/2010

 

Cefixime (PDF - 22KB)

 Draft  Oral  Capsule 203195 4/2013
Cefixime (PDF - 32KB) Draft Oral Tablet 65130 2/2011
Cefixime (PDF - 18KB)Revised Draft Oral Suspension

202091

11/2013
 Cefpodoxime Proxetil (PDF - 41KB)  Draft  Oral Suspension 65409   6/2012
 Cefpodoxime Proxetil (PDF - 41KB)  Draft  Oral Tablet 65462   6/2012
 Cefprozil (PDF - 40KB)  Draft  Oral Suspension 65261   6/2012
 Cefprozil (PDF - 39KB)  Draft  Oral Tablet 65276   6/2012
Cefuroxime Axetil (PDF - 33KB) Draft Oral Tablet 50605 8/2010
Cefuroxime Axetil (PDF - 16KB) Draft Oral Suspension 50672 2/2010
Celecoxib (PDF - 32KB)Revised Draft Oral Capsule 20998 11/2013
Cetirizine HCl(PDF - 46KB) Final Oral Tablet, Chewable 21621 5/2008
Cephalexin (PDF - 33KB) Final Oral Capsule 50405 10/2011
 Cetirizine HCl (PDF - 41KB)  Draft  Oral Tablet, Orally Disintegrating 22578   6/2012
Cetirizine Hydrochloride (PDF - 34KB) Draft Oral Capsule 22429 4/2011
Cetirizine HCl; Pseudoephedrine HCl (PDF - 60KB) Draft Oral Tablet, Extended Release 21150 2/2008
Cevimeline HCl (PDF - 48KB) Final Oral Capsule 20989 5/2008
Chlorambucil (PDF - 44KB) Draft Oral Tablet 10669 7/2010
Chlorpheniramine Polistirex; Hydrocodone Polistirex (PDF - 18KB) Draft Oral Suspension 19111 2/2010
Chlorpheniramine Polistirex; Hydrocodone Polistirex (PDF - 19KB) Draft Oral Capsule, Extended Release 77273 12/2008
Chlorpromazine HCl (PDF - 45KB)  Draft  Oral Tablet 80439  3/2012
Chlorthalidone (PDF - 36 KB) Draft Oral Tablet

86831

87180

19574

12/2009
Cholestyramine (PDF - 168KB) Revised  Draft Oral Powder

74557

74558

3/2012
Choline Fenofibrate (PDF - 39KB) Draft Oral Capsule, Delayed Release 22224 12/2010
Ciclesonide (PDF - 25KB) Draft Nasal Aerosol, Metered 202129 9/2012
Ciclopirox (PDF - 37KB) Draft Topical Suspension 19824 3/2010
Ciclopirox (PDF - 107KB) Draft Topical Cream 18748 2/2010
Ciclopirox (PDF - 80KB) Draft Topical Gel 20519 2/2010
Ciclopirox (PDF - 25KB) Draft Topical Shampoo 21159 2/2010
Ciclopirox (PDF - 22KB) Revised Draft Topical Solution 21022 2/2011
Cilostazol (PDF - 57KB) Final Oral Tablet 20863 5/2008
Cinacalcet HCl (PDF - 47KB) Final Oral Tablet 21688 5/2008
Ciprofloxacin (PDF - 33KB) Final Oral Suspension 20780 10/2011
Ciprofloxacin; Dexamethasone (PDF - 149KB Draft  Otic Suspension/Drops 21537 9/2012
 Ciprofloxacin HCl; Hydrocortisone (PDF - 239KB)   Draft  Otic Suspension/Drops 20805   6/2012
Ciprofloxacin HCl (PDF - 31KB) Draft Ophthalmic Drops, Solution 19992 6/2011
Ciprofloxacin HCl (PDF - 33KB) Draft Oral Tablet 19537 9/2010
Ciprofloxacin HCl (PDF - 80KB) Draft Oral Tablet, Extended Release 21744 11/2007
Ciprofloxacin; Ciprofloxacin HCl (PDF - 19KB) Draft Oral Tablet, Extended Release 21473 1/2008
Citalopram HBr (PDF - 16KB) Draft Oral Capsule 77668 9/2008
Citalopram HBr (PDF - 21KB) Draft Oral Tablet 20822 8/2008
Clarithromycin (PDF - 15KB) Draft Oral Tablet 50662 2/2010
Clarithromycin (PDF - 19KB) Draft Oral Tablet, Extended Release 50775 1/2008
Clarithromycin (PDF - 45KB) Final Oral Suspension 50698 5/2008
 Clindamycin HCL (PDF -31KB)  Draft Oral Capsule 50162 9/2011
Clindamycin Phosphate (PDF -230KB)  Draft  Vaginal Cream 50680  3/2012
Clindamycin Phosphate (PDF - 230KB)  Draft  Vaginal Cream 50793  3/2012
Clindamycin Phosphate (PDF - 227KB)  Draft  Vaginal Suppository 50767  3/2012
Clindamycin Phosphate (PDF - 43KB) Draft Topical Foam, Aerosol 50801 4/2011
Clindamycin Phosphate (PDF - 243KB) Draft Topical Gel 50615 4/2011
Clindamycin Phosphate (PDF - 225KB) Draft Topical Gel 50782 4/2011
Clindamycin Phosphate (PDF - 231KB) Draft Topical Lotion 50600 4/2011
Clindamycin Phosphate (PDF - 38KB) Draft Topical Solution 50537 4/2011
Clindamycin Phosphate (PDF - 34KB) Draft Topical Swab 50537 4/2011

 

Clindamycin Phosphate; Tretinoin (PDF -138 KB)

Draft Topical Gel

50802

50803

12/2012

Clobazam (PDF - 25KB)

Draft  Oral Suspension 203993 4/2014

Clobazam (PDF - 25KB) 

 Draft  Oral Tablet 202067 11/2013
Clobetasol Propionate (PDF -46KB) Draft Topical Foam, Aerosol 21142 2/2011
Clobetasol Propionate (PDF -33KB) Draft Topical Shampoo 21644 2/2011
Clobetasol Propionate (PDF -27KB) Draft Topical Spray 21835 2/2011
Clobetasol Propionate (PDF - 28KB) Draft Topical Solution 19966 8/2010
 Clomiphene Citrate (PDF - 33KB)  Draft  Oral Tablet 16131   6/2012
Clonazepam (PDF - 16KB) Draft Oral Tablet 17533 4/2010
Clonidine (PDF - 39KB) Draft Oral Tablet, Extended Release 22500 8/2010
Clonidine (PDF - 126KB) Draft Transdermal Film, Extended Relese 18891 11/2009
Clonidine HCl (PDF - 41KB) Final Oral Tablet 17407 5/2008
Clopidogrel Bisulfate (PDF - 21KB)
Revised
Draft Oral Tablet 20839 8/2008

 

 

Clorazepate Dipotassium (PDF - 67KB)

Draft Oral Tablet

17105

12/2012
Clotrimazole (PDF - 164KB)Revised Draft Topical Solution 74580 6/2011
Clotrimazole (PDF - 76KB) Draft Topical Cream 72640 3/2010
Clotrimazole (PDF - 78KB) Draft Vaginal Cream 18052 10/2009
Clotrimazole (PDF - 78KB) Draft Vaginal Cream 20574 10/2009
Clotrimazole (PDF - 82KB) Draft Vaginal Tablet 17717 10/2009
Clotrimazole (PDF - 81KB) Draft Vaginal Tablet 20525 10/2009
Clotrimazole (PDF - 46KB) Draft Oral Troche/Lozenge 76387 9/2008
Clozapine (PDF - 78 KB) Final Oral Tablet 19758 3/2011
Colchicine (PDF - 33KB) Draft Oral Tablet 22352 9/2010
Colesevelam HCl (PDF - 41KB)Revised Draft Oral Powder, Suspension 22362 6/2013
Colesevelam HCl (PDF - 18KB)
revised
Draft Oral Tablet 21176 11/2011
Cyclobenzaprine HCl (PDF - 25KB) Draft Oral Tablet 17821 2/2010
Cyclobenzaprine HCl (PDF - 23KB) Draft Oral Capsule, Extended Release 21777 8/2008
Cyclophosphamide (PDF -KB) Draft  Oral Tablet 040032 9/2012

 Cycloserine (PDF -22KB)  

Draft Oral Capsule

60593

6/2013

 Cyclosporine  (PDF - 24KB)

Draft Ophthalmic Emulsion

50790

6/2013