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U.S. Department of Health and Human Services

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'D'

 

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
 Dabigatran Etexilate Mesylate (PDF - 42KB) Draft OralCapsule22512 6/2012
Dalfampridine (PDF - 45KB) Draft OralTablet, Extended Release22250 3/2012
Dalteparin Sodium (PDF - 26KB)Draft Subcutaneous Injection202879/2012
Danazol (PDF-49KB)FinalOralCapsule745825/2008
Dantrolene Sodium (PDF-41KB)DraftOralCapsule768565/2007
Dapsone (PDF - 33KB)DraftOralTablet

86841 

86842

2/2011
Darifenacin HBr (PDF-46KB)FinalOralTablet, Extended Release215135/2008
Darunavir Ethanolate (PDF-49KB) RevisedDraftOralTablet219764/2013
Dasatinib (PDF - 41KB)DraftOralTablet219868/2010
Deferasirox (PDF-43KB)FinalOralTablet, For Suspension218825/2008
Delavirdine Mesylate (PDF-18KB)DraftOralTablet2070511/2007
Demeclocycline HCl (PDF-15KB)DraftOralTablet5026110/2008

 

Desipramine HCl (PDF -22KB)

DraftOralTablet

14399

4/2013
Desogestrel; Ethinyl Estradiol (PDF-16KB)  revisedDraftOralTablet203013/2010
Desogestrel; Ethinyl Estradiol (PDF-22KB)DraftOralTablet210903/2009
Desogestrel; Ethinyl Estradiol (PDF-19KB)
Revised
DraftOralTablet207137/2009
Desloratadine (PDF-53KB)FinalOralTablet, Orally Disintegrating213125/2008
Desloratadine (PDF-44KB)FinalOralTablet211655/2008
Desmopressin Acetate (PDF-33KB)RevisedDraftOralTablet1995512/2012
Desoximetasone (PDF - 25KB)DraftTopicalCream

073210

073193

4/2014

Desoximetasone (PDF - 42KB)

DraftTopicalOintment18594

74286

4/2014

 

 

Desvenlafaxine (PDF - 25KB)

DraftOralTablet, Extended Release

204150

4/2013
Desvenlafaxine Succinate (PDF-19KB)RevisedDraftOralTablet, Extended Release219926/2010
Dexamethasone (PDF - 38KB)DraftOralTablet

88316

84612

87916

88306

84610

84613

84611

6/2011
 Dexamethasone; Tobramycin (PDF - 64KB) Revised Draft OphthalmicOintment50616 6/2013
Dexamethasone; Tobramycin (PDF-49KB)RevisedDraftOphthalmicSuspension508186/2013
Dexamethasone;Tobramycin (PDF - 35 KB) RevisedDraftOphthalmicSuspension505926/2013
Dexlansoprazole (PDF - 47KB)DraftOralCapsule, Delayed Release222876/2011
Dexmethylphenidate (PDF-18KB)DraftOralTablet212782/2008
Dexmethylphenidate HCl (PDF - 130KB) Draft OralCapsule, Extended Release21802 3/2012
Dextroamphetamine Sulfate (PDF-18KB)DraftOralCapsule, Extended Release1707812/2008
Dextromethorphan Hydrobromide; Guaifenesin (PDF-18KB)DraftOralTablet, Extended Release2162012/2008
Dextromethorphan Hydrobromide; Quinidine Sulfate (PDF - 39KB)Revised Draft OralCapsule21879 4/2013
Dextromethorphan Polistirex (PDF-55KB)FinalOralSuspension, Extended Release186585/2008
Diazepam (PDF - 32KB)DraftRectalGel206487/2010

Diazoxide (PDF - 22KB)

DraftOralSuspension174534/2014
Diclofenac Epolamine (PDF - 595KB) DraftTopicalPatch21234 3/2012
Diclofenac Potassium (PDF - 33KB)DraftOralCapsule222024/2011
Diclofenac Sodium (PDF - 33KB)RevisedDraftTopicalSolution209476/2011
Diclofenac Sodium (PDF - 197KB)DraftTopicalGel221222/2011
Diclofenac Sodium (PDF - 172KB)DraftTopicalGel210051/2011
Diclofenac Sodium (PDF-18KB)DraftOralTablet, Delayed Release

19201

74376

10/2009
Diclofenac Sodium (PDF-18KB)DraftOralTablet, Extended Release2025410/2009
Diclofenac Sodium (PDF-19KB)DraftOphthalmicSolution/Drops200373/2009
Diclofenac sodium; misoprostol (PDF-18KB)
revised
FinalOralTablet, Delayed Release2060712/2009
Dicloxacillin Sodium (PDF-41KB)FinalOralCapsule614545/2008
Didanosine (PDF-41KB) RevisedFinalOralTablet, Chewable772756/2013
Didanosine (PDF-44KB)FinalOralCapsule, Delayed Release Pellets211835/2008

Dienogest;Estradiol Valerate (PDF - 38KB)

DraftOralTablet2225212/2010
Diethylpropion HCl (PDF - 20 KB)DraftOralTablet, Extended Release1254612/2009
Diflunisal (PDF-15KB)DraftOralTablet73673Revised12/2012
Digoxin (PDF-53KB)FinalOralTablet204055/2008
Diltiazem HCl (PDF-19KB)DraftOralCapsule, Extended Release200622/2008
Diltiazem HCl (PDF-20KB)DraftOralCapsule, Extended Release200922/2008
Diltiazem HCl (PDF-21KB)DraftOralCapsule, Extended Release204012/2008
Diltiazem HCl (PDF-19KB)DraftOralTablet, Extended Release213922/2008
 Dinoprostone (PDF - 162KB) Draft VaginalSuppository17810 6/2012
Dinoprostone (PDF - 155KB) DraftVaginalInsert, Extended Release2041111/2011
 Dinoprostone (PDF - 159KB) DraftEndocervicalGel196179/2011
Diphenhydramine Citrate;Ibuprofen (PDF-26KB)DraftOralTablet213942/2010
 Diphenhydramine HCl and Ibuprofen (PDF - 33KB) Draft OralCapsule213936/2012
Dipyridamole (PDF-41KB)RevisedDraftOralTablet1283612/2012
Disopyramide Phosphate (PDF-20KB)DraftOralCapsule174478/2008
Disopyramide Phosphate (PDF-16KB)DraftOralCapsule, Extended Release1865510/2008
Disulfiram (PDF - 26 KB)RevisedDraftOralTablet

88482

88483

6/2011
Divalproex Sodium (PDF-19KB)DraftOralTablet, Delayed Release1872312/2009
Divalproex Sodium (PDF-19KB)FinalOralCapsule, Delayed Release Pellets196805/2008
Divalproex Sodium (PDF-57KB)DraftOralTablet, Extended Release211682/2008
Dofetilide (PDF-43KB)FinalOralCapsule209315/2008
Dolasetron Mesylate (PDF - 36KB)DraftOralTablet206235/2010
Donepezil HCl (PDF - 49KB)DraftOralTablet2256812/2010
Donepezil HCl (PDF-22KB)
Revised
FinalOralTablet, Orally Disintegrating217204/2010
Donepezil HCl (PDF-22KB)
Revised
FinalOralTablet206904/2010
Doxazosin Mesylate (PDF - 35KB)DraftOralTablet196688/2010
Doxazosin Mesylate (PDF-47KB)FinalOralTablet, Extended Release212695/2008
Doxepin HCl (PDF - 34KB)DraftOralTablet220369/2010
Doxepin HCl (PDF - 35KB)DraftOralCapsule

70791

8/2010
Doxercalciferol (PDF-30KB)
Revised
DraftOralCapsule208627/2009
Doxorubicin HCl (PDF-66KB)RevisedDraftInjectableInjection, Liposome20326311/2013
Doxycycline (PDF-18KB)DraftOralCapsule, Delayed Release508052/2008
Doxycycline (PDF-18KB)DraftOralTablet650701/2008
Doxycycline (PDF-17KB)DraftOralSuspension500068/2008
Doxycycline Hyclate (PDF-16KB)DraftOralCapsule500077/2008
Doxycycline Hyclate (PDF-19KB) RevisedDraftOralTablet, Delayed Release507952/2014
Dronabinol (PDF-25KB) RevisedDraftOralCapsule186512/2014

Dronedarone HCl (PDF - 62KB) Revised

DraftOralTablet224257/2014
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium (PDF - 52KB) Draft OralTablet

22532

22574

 3/2012
Drospirenone; Estradiol (PDF-43KB) RevisedFinalOralTablet213556/2013
Drospirenone; Ethinyl Estradiol (PDF-21KB)RevisedDraftOralTablet2167611/2013
Drospirenone; Ethinyl Estradiol (PDF-21KB)DraftOralTablet210983/2009
Duloxetine HCl (PDF-57KB) RevisedFinalOralCapsule, Delayed Release Pellets214277/2014
Dutasteride (PDF-55KB)FinalOralCapsule213195/2008
Dutasteride;Tamsulosin HCl (PDF -62KB) RevisedDraft OralCapsule0224602/2014