Drugs

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

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
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 020273 9/2010
Calcipotriene (PDF - 31KB) Draft Topical Solution 20611 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 019976 5/2017
Calcium Acetate (PDF - 16KB) Revised Draft Oral Capsule 21160 5/2017
 

Calcium carbonate; Famotidine; Magnesium hydroxide (PDF - 23KB)

Draft Oral Tablet, Chewable 20958 6/2015

Canagliflozin (PDF - 24KB)

Draft  Oral Tablet 204042 7/2014

Canagliflozin; Metformin HCl (PDF -24KB)

Draft Oral Tablet 204353 6/2015
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

Captopril (PDF - 38KB)

Draft Oral Tablet 018343 10/2016
Carbamazepine (PDF - 35KB)Revised Draft Oral Tablet 16608 9/2015
Carbamazepine (PDF - 19KB) Revised Draft Oral Tablet, Extended Release 20234 3/2015
Carbamazepine (PDF - 42KB) Revised Draft Oral Capsule, Extended Release 20712 3/2015
Carbamazepine(PDF - 42KB) Revised Draft Oral Suspension 18927 3/2015

Carbidopa (PDF - 23KB)

Draft Oral Tablet 017830 7/2014
Carbidopa; Entacapone; Levodopa (PDF - 16KB)
Revised
Draft Oral Tablet 21485 6/2013

Carbidopa; levodopa (PDF - 49KB)

Draft Enteral Suspension 203952 5/2017

Carbidopa; Levodopa (PDF - 34KB)

Draft Oral Tablet 17555 10/2016

Carbidopa; levodopa (PDF - 42KB)

Draft Oral Capsule, Extended Release 203312 9/2015
Carbidopa; Levodopa (PDF - 19KB) Draft  Oral  Tablet, Extended Release 19856 9/2012
Carbidopa; Levodopa (PDF - 16KB) Draft Oral Tablet, Orally Disintegrating 78893 2/2010

Carbinoxamine Maleate (PDF -26KB)

Draft Oral Suspension, Extended Release 22556 7/2014
Carglumic Acid (PDF - 17KB) Draft  Oral Tablet 22562 9/2012

Cariprazine HCl (PDF - 40KB)

 Draft  Oral

Capsule

204370 6/2016
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 050521 2/2011
Cefadroxil; Cefadroxil Hemihydrate (PDF - 36KB) Draft Oral Capsule 050512 9/2010
Cefdinir (PDF - 18KB) Revised Draft Oral Capsule 50739 9/2010

Cefdinir (PDF - 38KB)

Draft Oral Powder for Suspension 050749 7/2017
Cefditoren Pivoxil (PDF - 38KB) Final Oral Tablet 21222 3/2010

Cefixime  (PDF - 23KB)

Draft Oral Tablet, Chewable 65380 7/2014

 

Cefixime (PDF - 22KB)

 Draft  Oral  Capsule 203195 4/2013
Cefixime (PDF - 32KB) Draft Oral Tablet 50621 2/2011
Cefixime (PDF - 18KB)Revised Draft Oral Suspension

202091

11/2013
Cefpodoxime Proxetil (PDF - 41KB)  Draft  Oral Suspension 50675   6/2012
Cefpodoxime Proxetil (PDF - 41KB)  Draft  Oral Tablet 050674   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

Cephalexin (PDF - 37KB)

Draft Oral Suspension 50406 12/2016
Cephalexin (PDF - 33KB) Final Oral Capsule 50405 10/2011

Ceritinib (PDF - 38KB)

Draft  Oral Capsule 205755 9/2015
Cetirizine HCl(PDF - 46KB) Final Oral Tablet, Chewable 21621 5/2008
Cetirizine HCl (PDF - 41KB)  Draft  Oral Tablet, Orally Disintegrating 22578   6/2012

Cetirizine hydrochloride (PDF - 40KB)

Draft Oral Tablet 019835 12/2016
Cetirizine Hydrochloride (PDF - 34KB) Final Oral Capsule 22429 8/2017
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

Chlordiazepoxide hydrochloride; clidinium bromide (PDF - 40KB)

Draft Oral Capsule 012750 5/2017

Chlorpheniramine maleate; Ibuprofen; Phenylephrine hydrochloride (PDF - 23KB)

Draft Oral Tablet 022113 3/2015

Chlorpheniramine polistirex; codeine polistirex (PDF - 41KB)

Draft Oral Suspension, Extended Release 207768 4/2016
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

084112

084114

 3/2012
Chlorthalidone (PDF - 36 KB) Final Oral Tablet

12283

8/2017
Cholestyramine (PDF - 168KB) Revised  Draft Oral Powder

019669

6/2015

Cholic Acid (PDF - 39KB)

Draft Oral Capsule 205750 10/2016
Choline Fenofibrate (PDF - 39KB) Revised Draft Oral Capsule, Delayed Release 22224 12/2010
Ciclesonide (PDF - 25KB) Draft Nasal Aerosol, Metered 202129 9/2012
 Ciclesonide (PDF - 102KB) Draft Inhalation Aerosol, metered 021658 1/2016
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 Revised Draft  Otic Suspension/Drops 21537 4/2016
 Ciprofloxacin HCl; Hydrocortisone (PDF - 239KB) Revised  Draft  Otic Suspension/Drops 20805  1/2016
Ciprofloxacin HCl (PDF - 31KB) Revised Draft Ophthalmic Drops, Solution 19992 8/2017
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) Final Oral Capsule 77668 8/2017
Citalopram HBr (PDF - 21KB) Final Oral Tablet 20822 8/2017
Clarithromycin (PDF - 15KB) Final Oral Tablet 50662 8/2017
Clarithromycin (PDF - 19KB) Draft Oral Tablet, Extended Release 50775 1/2008
Clarithromycin (PDF - 45KB) Final Oral Suspension 50698 5/2008
Clindamycin HCL (PDF -31KB) Final Oral Capsule 50162 8/2017
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 - 38KB)

Draft Topical Cream (emollient) 020340 10/2016

Clobetasol propionate (PDF - 38KB)

Draft  Topical Gel 020337 10/2016

Clobetasol propionate (PDF - 38KB)

Draft Topical Cream 19322 4/2016

Clobetasol propionate (PDF - 38KB)

Draft Topical Lotion 21535 4/2016

Clobetasol propionate (PDF - 39KB)

Draft Topical Aerosol, foam 22013 9/2015
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

Clobetasol propionate (PDF - 38KB)

Draft Topical Ointment 019323 1/2016

Clocortolone pivalate (PDF - 35KB)

Draft Topical Cream 017765 7/2017
Clomiphene Citrate (PDF - 33KB) Final  Oral Tablet 16131 8/2017

Clomipramine HCl (PDF - 41KB)

Draft Oral Capsule 019906 9/2015

Clonazepam (PDF - 39KB)

Draft Oral Tablets, disintegrating 020813 5/2017
Clonazepam (PDF - 16KB) Final Oral Tablet 17533 8/2017
Clonidine (PDF - 39KB) Draft Oral Tablet, Extended Release 22500 8/2010
Clonidine (PDF - 126KB)  Revised Draft Transdermal Film, Extended Relese 18891 10/2016

Clonidine HCl (PDF - 42KB)

Draft Oral Tablet, Extended Release 022331 9/2015
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 018181 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 018713 9/2008

Clozapine (PDF - 70KB)

Draft Oral Suspension 203479 12/2016
Clozapine (PDF - 78 KB) Draft Oral Tablet 19758 3/2011
Clozapine (PDF - 22 KB) Final Oral Tablet, Orally Disintegrating 21590 8/2017

Cobicistat (PDF - 41KB)

Draft Oral Tablet 203094 9/2015
  

Cobicistat; darunavir ethanolate  (PDF -39KB) Revised

Draft Oral Tablet 205395 12/2016

Cobicistat; Elvitegravir; Emtricitabine; Tenofovir alafenamide fumarate (PDF - 35KB) Revised

Draft Oral Tablet 207561 8/2017
Cobicistat;Elvitegravir;Emtricitabine;Tenofovir disoproxil fumarate (PDF -24KB) Draft Oral Tablet 203100 12/2014

Cobimetinib fumarate (PDF -58KB)

 Draft Oral Tablet 206192 6/2016
 

Colchicine (PDF - 38KB)

Draft Oral Capsule 204820 12/2016
Colchicine (PDF - 33KB) Draft Oral Tablet 22352 9/2010
Colesevelam HCl (PDF - 41KB) Revised Draft Oral Powder, Suspension 22362 1/2016
Colesevelam HCl (PDF - 18KB)
revised
Draft Oral Tablet 21176 9/2015

Colestipol Hydrochloride (PDF - 26KB)

Draft  Oral Tablet 20222 7/2014
Conjugated estrogens (PDF - 223KB) Draft Oral Tablet 004782 12/2014

Crizotinib (PDF -44KB)

Draft Oral Capsule 202570 7/2014

Crotamiton (PDF - 37KB)

Draft Topical Cream 006927 10/2016

Crotamiton (PDF - 38KB)

Draft Topical Lotion 009112 10/2016

Cyanocobalamin (PDF - 45KB)

Draft Nasal Spray 021642 7/2017
Cyclobenzaprine HCl (PDF - 25KB) Final Oral Tablet 17821 8/2017

Cyclobenzaprine HCl (PDF - 26KB)Revised

Draft Oral Capsule, Extended Release 21777 11/2016
Cyclophosphamide (PDF -KB) Draft  Oral Tablet 040032 9/2015

Cyclophosphamide (PDF - 43KB)

Draft  Oral Capsule 203856 6/2015

Cycloserine (PDF -22KB)  

Final Oral Capsule

60593

8/2017
Cyclosporine (PDF - 40KB) Revised Draft Oral Capsule 050625 4/2016
Cyclosporine (PDF - 40KB) Revised Draft Oral Capsule 050715 4/2016

Cyclosporine  (PDF - 24KB) Revised

Draft Ophthalmic Emulsion

50790

10/2016

Cyproheptadine HCl (PDF - 37KB)

Draft Oral Tablet 012649 6/2015

Cysteamine bitartrate (PDF - 30KB)

Draft  Oral Capsule, Delayed Release 203389 9/2015

 

Page Last Updated: 09/20/2017
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