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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 '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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
 Dabigatran Etexilate Mesylate (PDF - 42KB)  Draft  Oral Capsule 22512  6/2012
Dalfampridine (PDF - 45KB)  Draft  Oral Tablet, Extended Release 22250  3/2012
Dalteparin Sodium (PDF - 26KB) Draft  Subcutaneous  Injection 20287 9/2012
Danazol (PDF-49KB) Final Oral Capsule 74582 5/2008
Dantrolene Sodium (PDF-41KB) Draft Oral Capsule 76856 5/2007
Dapsone (PDF - 33KB) Draft Oral Tablet

86841 

86842

2/2011
Darifenacin HBr (PDF-46KB) Final Oral Tablet, Extended Release 21513 5/2008
Darunavir Ethanolate (PDF-49KB) Revised Draft Oral Tablet 21976 4/2013
Dasatinib (PDF - 41KB) Draft Oral Tablet 21986 8/2010
Deferasirox (PDF-43KB) Final Oral Tablet, For Suspension 21882 5/2008
Delavirdine Mesylate (PDF-18KB) Draft Oral Tablet 20705 11/2007
Demeclocycline HCl (PDF-15KB) Draft Oral Tablet 50261 10/2008

 

Desipramine HCl (PDF -22KB)

Draft Oral Tablet

14399

4/2013
Desogestrel; Ethinyl Estradiol (PDF-16KB)  revised Draft Oral Tablet 20301 3/2010
Desogestrel; Ethinyl Estradiol (PDF-22KB) Draft Oral Tablet 21090 3/2009
Desogestrel; Ethinyl Estradiol (PDF-19KB)
Revised
Draft Oral Tablet 20713 7/2009
Desloratadine (PDF-53KB) Final Oral Tablet, Orally Disintegrating 21312 5/2008
Desloratadine (PDF-44KB) Final Oral Tablet 21165 5/2008
Desmopressin Acetate (PDF-33KB)Revised Draft Oral Tablet 19955 12/2012

 

 

Desvenlafaxine (PDF - 25KB)

Draft Oral Tablet, Extended Release

204150

4/2013
Desvenlafaxine Succinate (PDF-19KB)Revised Draft Oral Tablet, Extended Release 21992 6/2010
Dexamethasone (PDF - 38KB) Draft Oral Tablet

88316

84612

87916

88306

84610

84613

84611

6/2011
 Dexamethasone; Tobramycin (PDF - 64KB) Revised  Draft  Ophthalmic Ointment 50616  6/2013
Dexamethasone; Tobramycin (PDF-49KB)Revised Draft Ophthalmic Suspension 50818 6/2013
Dexamethasone;Tobramycin (PDF - 35 KB) Revised Draft Ophthalmic Suspension 50592 6/2013
Dexlansoprazole (PDF - 47KB) Draft Oral Capsule, Delayed Release 22287 6/2011
Dexmethylphenidate (PDF-18KB) Draft Oral Tablet 21278 2/2008
Dexmethylphenidate HCl (PDF - 130KB)  Draft  Oral Capsule, Extended Release 21802  3/2012
Dextroamphetamine Sulfate (PDF-18KB) Draft Oral Capsule, Extended Release 17078 12/2008
Dextromethorphan Hydrobromide; Guaifenesin (PDF-18KB) Draft Oral Tablet, Extended Release 21620 12/2008
Dextromethorphan Hydrobromide; Quinidine Sulfate (PDF - 39KB)Revised  Draft  Oral Capsule 21879  4/2013
Dextromethorphan Polistirex (PDF-55KB) Final Oral Suspension, Extended Release 18658 5/2008
Diazepam (PDF - 32KB) Draft Rectal Gel 20648 7/2010
Diclofenac Epolamine (PDF - 595KB)  Draft Topical Patch 21234  3/2012
Diclofenac Potassium (PDF - 33KB) Draft Oral Capsule 22202 4/2011
Diclofenac Sodium (PDF - 33KB)Revised Draft Topical Solution 20947 6/2011
Diclofenac Sodium (PDF - 197KB) Draft Topical Gel 22122 2/2011
Diclofenac Sodium (PDF - 172KB) Draft Topical Gel 21005 1/2011
Diclofenac Sodium (PDF-18KB) Draft Oral Tablet, Delayed Release

19201

74376

10/2009
Diclofenac Sodium (PDF-18KB) Draft Oral Tablet, Extended Release 20254 10/2009
Diclofenac Sodium (PDF-19KB) Draft Ophthalmic Solution/Drops 20037 3/2009
Diclofenac sodium; misoprostol (PDF-18KB)
revised
Final Oral Tablet, Delayed Release 20607 12/2009
Dicloxacillin Sodium (PDF-41KB) Final Oral Capsule 61454 5/2008
Didanosine (PDF-41KB) Revised Final Oral Tablet, Chewable 77275 6/2013
Didanosine (PDF-44KB) Final Oral Capsule, Delayed Release Pellets 21183 5/2008

Dienogest;Estradiol Valerate (PDF - 38KB)

Draft Oral Tablet 22252 12/2010
Diethylpropion HCl (PDF - 20 KB) Draft Oral Tablet, Extended Release 12546 12/2009
Diflunisal (PDF-15KB) Draft Oral Tablet 73673Revised 12/2012
Digoxin (PDF-53KB) Final Oral Tablet 20405 5/2008
Diltiazem HCl (PDF-19KB) Draft Oral Capsule, Extended Release 20062 2/2008
Diltiazem HCl (PDF-20KB) Draft Oral Capsule, Extended Release 20092 2/2008
Diltiazem HCl (PDF-21KB) Draft Oral Capsule, Extended Release 20401 2/2008
Diltiazem HCl (PDF-19KB) Draft Oral Tablet, Extended Release 21392 2/2008
 Dinoprostone (PDF - 162KB)  Draft  Vaginal Suppository 17810  6/2012
Dinoprostone (PDF - 155KB)  Draft Vaginal Insert, Extended Release 20411 11/2011
 Dinoprostone (PDF - 159KB)  Draft Endocervical Gel 19617 9/2011
Diphenhydramine Citrate;Ibuprofen (PDF-26KB) Draft Oral Tablet 21394 2/2010
 Diphenhydramine HCl and Ibuprofen (PDF - 33KB)  Draft  Oral Capsule 21393 6/2012
Dipyridamole (PDF-41KB)Revised Draft Oral Tablet 12836 12/2012
Disopyramide Phosphate (PDF-20KB) Draft Oral Capsule 17447 8/2008
Disopyramide Phosphate (PDF-16KB) Draft Oral Capsule, Extended Release 18655 10/2008
Disulfiram (PDF - 26 KB)Revised Draft Oral Tablet

88482

88483

6/2011
Divalproex Sodium (PDF-19KB) Draft Oral Tablet, Delayed Release 18723 12/2009
Divalproex Sodium (PDF-19KB) Final Oral Capsule, Delayed Release Pellets 19680 5/2008
Divalproex Sodium (PDF-57KB) Draft Oral Tablet, Extended Release 21168 2/2008
Dofetilide (PDF-43KB) Final Oral Capsule 20931 5/2008
Dolasetron Mesylate (PDF - 36KB) Draft Oral Tablet 20623 5/2010
Donepezil HCl (PDF - 49KB) Draft Oral Tablet 22568 12/2010
Donepezil HCl (PDF-22KB)
Revised
Final Oral Tablet, Orally Disintegrating 21720 4/2010
Donepezil HCl (PDF-22KB)
Revised
Final Oral Tablet 20690 4/2010
Doxazosin Mesylate (PDF - 35KB) Draft Oral Tablet 19668 8/2010
Doxazosin Mesylate (PDF-47KB) Final Oral Tablet, Extended Release 21269 5/2008
Doxepin HCl (PDF - 34KB) Draft Oral Tablet 22036 9/2010
Doxepin HCl (PDF - 35KB) Draft Oral Capsule

70791

8/2010
Doxercalciferol (PDF-30KB)
Revised
Draft Oral Capsule 20862 7/2009
Doxorubicin HCl (PDF-66KB)Revised Draft Injectable Injection, Liposome 203263 11/2013
Doxycycline (PDF-18KB) Draft Oral Capsule, Delayed Release 50805 2/2008
Doxycycline (PDF-18KB) Draft Oral Tablet 65070 1/2008
Doxycycline (PDF-17KB) Draft Oral Suspension 50006 8/2008
Doxycycline Hyclate (PDF-16KB) Draft Oral Capsule 50007 7/2008
Doxycycline Hyclate (PDF-19KB) Revised Draft Oral Tablet, Delayed Release 50795 2/2014
Dronabinol (PDF-25KB) Revised Draft Oral Capsule 18651 2/2014

Dronedarone Hydrochoride

Draft Oral Tablet 22425 11/2010
Drospirenone; Ethinyl Estradiol; Levomefolate Calcium (PDF - 52KB)  Draft  Oral Tablet

22532

22574

 3/2012
Drospirenone; Estradiol (PDF-43KB) Revised Final Oral Tablet 21355 6/2013
Drospirenone; Ethinyl Estradiol (PDF-21KB)Revised Draft Oral Tablet 21676 11/2013
Drospirenone; Ethinyl Estradiol (PDF-21KB) Draft Oral Tablet 21098 3/2009
Duloxetine HCl (PDF-57KB) Final Oral Capsule, Delayed Release Pellets 21427 5/2008
Dutasteride (PDF-55KB) Final Oral Capsule 21319 5/2008
Dutasteride;Tamsulosin HCl (PDF -62KB) Revised Draft  Oral Capsule 022460 2/2014