Drugs

Product-Specific Recommendations for Generic Drug Development: 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Calcipotriene (PDF - 277KB)DraftTopicalFoam225631/2011
Calcipotriene (PDF - 295KB)DraftTopicalCream205548/2010
Calcipotriene (PDF - 54KB) RevisedDraftTopicalOintment906339/2010
Calcipotriene (PDF - 31KB)DraftTopicalSolution770298/2010
Calcitonin-Salmon (PDF - 21KB)Draft NasalSpray, Metered203139/2012
Calcitriol (PDF - 43KB) RevisedDraftOralCapsule180449/2010
Calcium Acetate (PDF - 16KB)RevisedDraftOralTablet785026/2011
Calcium Acetate (PDF - 16KB)RevisedDraftOralCapsule211606/2011

 Canagliflozin (PDF - 24KB)

Draft OralTablet2040427/2014
Candesartan Cilexetil (PDF - 56KB)FinalOralTablet208385/2008
Candesartan Cilexetil; Hydrochlorothiazide (PDF - 15KB)
Revised
DraftOralTablet210939/2008
Capecitabine (PDF - 46KB) RevisedDraftOralTablet208969/2012
Carbamazepine (PDF - 35KB)DraftOralTablet166088/2011
Carbamazepine (PDF - 19KB) RevisedDraftOralTablet, Extended Release202343/2015
Carbamazepine (PDF - 42KB) RevisedDraftOralCapsule, Extended Release207123/2015
Carbamazepine(PDF - 42KB) RevisedDraftOralSuspension189273/2015

 Carbidopa (PDF - 23KB)

DraftOralTablet0178307/2014
Carbidopa; Entacapone; Levodopa (PDF - 16KB)
Revised
DraftOralTablet214856/2013
Carbidopa; Levodopa (PDF - 19KB)Draft Oral Tablet, Extended Release198569/2012
Carbidopa; Levodopa (PDF - 16KB)DraftOralTablet, Orally Disintegrating788932/2010

 Carbinoxamine Maleate (PDF -26KB)

DraftOralSuspension, Extended Release225567/2014
Carglumic Acid (PDF - 17KB)Draft OralTablet225629/2012
Carisoprodol (PDF - 18KB)DraftOralTablet117923/2010
Carvedilol (PDF - 49KB)FinalOralTablet202975/2008
Carvedilol Phosphate (PDF - 30KB)DraftOralCapsule, Extended Release220122/2010
Cefaclor (PDF - 34KB)DraftOralCapsule653502/2011
Cefadroxil; Cefadroxil Hemihydrate (PDF - 36KB)DraftOralCapsule652829/2010
Cefdinir (PDF - 18KB) RevisedDraftOralCapsule653309/2010
Cefditoren Pivoxil (PDF - 18KB)DraftOralTablet212223/2010
Cefditoren Pivoxil (PDF - 16KB) RevisedFinalOralTablet212222/2010

Cefixime  (PDF - 23KB)

DraftOralTablet, Chewable653807/2014

 

Cefixime (PDF - 22KB)

 Draft Oral Capsule2031954/2013
Cefixime (PDF - 32KB)DraftOralTablet651302/2011
Cefixime (PDF - 18KB)RevisedDraftOralSuspension

202091

11/2013
 Cefpodoxime Proxetil (PDF - 41KB) Draft OralSuspension65409  6/2012
 Cefpodoxime Proxetil (PDF - 41KB) Draft OralTablet65462  6/2012
 Cefprozil (PDF - 40KB) Draft OralSuspension65261  6/2012
 Cefprozil (PDF - 39KB) Draft OralTablet65276  6/2012
Cefuroxime Axetil (PDF - 33KB)DraftOralTablet506058/2010
Cefuroxime Axetil (PDF - 16KB)DraftOralSuspension506722/2010
Celecoxib (PDF - 32KB)RevisedDraftOralCapsule2099811/2013
Cetirizine HCl(PDF - 46KB)FinalOralTablet, Chewable216215/2008
Cephalexin (PDF - 33KB)FinalOralCapsule5040510/2011
 Cetirizine HCl (PDF - 41KB) Draft OralTablet, Orally Disintegrating22578  6/2012
Cetirizine Hydrochloride (PDF - 34KB)DraftOralCapsule224294/2011
Cetirizine HCl; Pseudoephedrine HCl (PDF - 60KB)DraftOralTablet, Extended Release211502/2008
Cevimeline HCl (PDF - 48KB)FinalOralCapsule209895/2008
Chlorambucil (PDF - 44KB)DraftOralTablet106697/2010

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

DraftOralTablet0221133/2015
Chlorpheniramine Polistirex; Hydrocodone Polistirex (PDF - 18KB)DraftOralSuspension191112/2010
Chlorpheniramine Polistirex; Hydrocodone Polistirex (PDF - 19KB)DraftOralCapsule, Extended Release7727312/2008
Chlorpromazine HCl (PDF - 45KB) Draft OralTablet80439 3/2012
Chlorthalidone (PDF - 36 KB)DraftOralTablet

86831

19574

12/2009
Cholestyramine (PDF - 168KB) Revised DraftOralPowder

74557

74558

6/2015
Choline Fenofibrate (PDF - 39KB)DraftOralCapsule, Delayed Release2222412/2010
Ciclesonide (PDF - 25KB)DraftNasalAerosol, Metered2021299/2012
Ciclopirox (PDF - 37KB)DraftTopicalSuspension198243/2010
Ciclopirox (PDF - 107KB)DraftTopicalCream187482/2010
Ciclopirox (PDF - 80KB)DraftTopicalGel205192/2010
Ciclopirox (PDF - 25KB)DraftTopicalShampoo211592/2010
Ciclopirox (PDF - 22KB) RevisedDraftTopicalSolution210222/2011
Cilostazol (PDF - 57KB)FinalOralTablet208635/2008
Cinacalcet HCl (PDF - 47KB)FinalOralTablet216885/2008
Ciprofloxacin (PDF - 33KB)FinalOralSuspension2078010/2011
Ciprofloxacin; Dexamethasone (PDF - 149KB RevisedDraft OticSuspension/Drops215373/2015
 Ciprofloxacin HCl; Hydrocortisone (PDF - 239KB)  Draft OticSuspension/Drops20805  6/2012
Ciprofloxacin HCl (PDF - 31KB)DraftOphthalmicDrops, Solution199926/2011
Ciprofloxacin HCl (PDF - 33KB)DraftOralTablet195379/2010
Ciprofloxacin HCl (PDF - 80KB)DraftOralTablet, Extended Release2174411/2007
Ciprofloxacin; Ciprofloxacin HCl (PDF - 19KB)DraftOralTablet, Extended Release214731/2008
Citalopram HBr (PDF - 16KB)DraftOralCapsule776689/2008
Citalopram HBr (PDF - 21KB)DraftOralTablet208228/2008
Clarithromycin (PDF - 15KB)DraftOralTablet506622/2010
Clarithromycin (PDF - 19KB)DraftOralTablet, Extended Release507751/2008
Clarithromycin (PDF - 45KB)FinalOralSuspension506985/2008
 Clindamycin HCL (PDF -31KB) DraftOralCapsule501629/2011
Clindamycin Phosphate (PDF -230KB) Draft VaginalCream50680 3/2012
Clindamycin Phosphate (PDF - 230KB) Draft VaginalCream50793 3/2012
Clindamycin Phosphate (PDF - 227KB) Draft VaginalSuppository50767 3/2012
Clindamycin Phosphate (PDF - 43KB)DraftTopicalFoam, Aerosol508014/2011
Clindamycin Phosphate (PDF - 243KB)DraftTopicalGel506154/2011
Clindamycin Phosphate (PDF - 225KB)DraftTopicalGel507824/2011
Clindamycin Phosphate (PDF - 231KB)DraftTopicalLotion506004/2011
Clindamycin Phosphate (PDF - 38KB)DraftTopicalSolution505374/2011
Clindamycin Phosphate (PDF - 34KB)DraftTopicalSwab505374/2011

 

Clindamycin Phosphate; Tretinoin (PDF -138 KB)

DraftTopicalGel

50802

50803

12/2012

Clobazam (PDF - 25KB)

Draft OralSuspension2039934/2014

Clobazam (PDF - 25KB) 

 Draft OralTablet20206711/2013
Clobetasol Propionate (PDF -46KB)DraftTopicalFoam, Aerosol211422/2011
Clobetasol Propionate (PDF -33KB)DraftTopicalShampoo216442/2011
Clobetasol Propionate (PDF -27KB)DraftTopicalSpray218352/2011
Clobetasol Propionate (PDF - 28KB)DraftTopicalSolution199668/2010
 Clomiphene Citrate (PDF - 33KB) Draft OralTablet16131  6/2012
Clonazepam (PDF - 16KB)DraftOralTablet175334/2010
Clonidine (PDF - 39KB)DraftOralTablet, Extended Release225008/2010
Clonidine (PDF - 126KB)DraftTransdermalFilm, Extended Relese1889111/2009
Clonidine HCl (PDF - 41KB)FinalOralTablet174075/2008
Clopidogrel Bisulfate (PDF - 21KB)
Revised
DraftOralTablet208398/2008

 

 

Clorazepate Dipotassium (PDF - 67KB)

DraftOralTablet

17105

12/2012
Clotrimazole (PDF - 164KB)RevisedDraftTopicalSolution745806/2011
Clotrimazole (PDF - 76KB)DraftTopicalCream726403/2010
Clotrimazole (PDF - 78KB)DraftVaginalCream1805210/2009
Clotrimazole (PDF - 78KB)DraftVaginalCream2057410/2009
Clotrimazole (PDF - 82KB)DraftVaginalTablet1771710/2009
Clotrimazole (PDF - 81KB)DraftVaginalTablet2052510/2009
Clotrimazole (PDF - 46KB)DraftOralTroche/Lozenge763879/2008
Clozapine (PDF - 78 KB)DraftOralTablet215903/2011
Clozapine (PDF - 22 KB)FinalOralTablet, Orally Disintegrating197585/5/2015
Cobicistat;Elvitegravir;Emtricitabine;Tenofovir disoproxil fumarate (PDF -24KB)DraftOralTablet20310012/2014
Colchicine (PDF - 33KB)DraftOralTablet223529/2010
Colesevelam HCl (PDF - 41KB)RevisedDraftOralPowder, Suspension223626/2013
Colesevelam HCl (PDF - 18KB)
revised
DraftOralTablet2117611/2011

Colestipol Hydrochloride (PDF - 26KB)

Draft OralTablet202227/2014
Conjugated estrogens (PDF - 223KB)DraftOralTablet00478212/2014

Crizotinib (PDF -44KB)

DraftOralCapsule2025707/2014
Cyclobenzaprine HCl (PDF - 25KB)DraftOralTablet0731442/2010
Cyclobenzaprine HCl (PDF - 23KB)DraftOralCapsule, Extended Release217778/2008
Cyclophosphamide (PDF -KB)Draft OralTablet0400329/2012

Cycloserine (PDF -22KB)  

DraftOralCapsule

60593

6/2013
Cyclosporine (PDF - 40KB)DraftOralCapsule0506253/2015
Cyclosporine (PDF - 40KB)DraftOralCapsule (modified)0507153/2015

 Cyclosporine  (PDF - 24KB)

DraftOphthalmicEmulsion

50790

6/2013

 

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