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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'D'
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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 | 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 |
| 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 Succinate (PDF-19KB)Revised | Draft | Oral | Tablet, Extended Release | 21992 | 6/2010 |
| Dexamethasone (PDF - 38KB) | Draft | Oral | Tablet | 6/2011 | |
| Dexamethasone; Tobramycin (PDF - 64KB) | Draft | Ophthalmic | Ointment | 50616 | 11/2012 |
| Dexamethasone; Tobramycin (PDF-49KB)Revised | Draft | Ophthalmic | Suspension | 50818 | 6/2012 |
| Dexamethasone;Tobramycin (PDF - 35 KB) Revised | Draft | Ophthalmic | Suspension | 50592 | 6/2012 |
| 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 | 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) | Final | Oral | Tablet, Chewable | 77275 | 5/2008 |
| Didanosine (PDF-44KB) | Final | Oral | Capsule, Delayed Release Pellets | 21183 | 5/2008 |
| 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 | 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 | 8/2010 | |
| Doxercalciferol (PDF-30KB) Revised |
Draft | Oral | Capsule | 20862 | 7/2009 |
| Doxorubicin HCl (PDF-66KB) | Draft | Injectable | Injection, Liposome | 50718 | 2/2010 |
| 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) | Draft | Oral | Tablet, Delayed Release | 50795 | 5/2009 |
| Dronabinol (PDF-25KB) | Draft | Oral | Capsule | 18651 | 2/2010 |
| Draft | Oral | Tablet | 22425 | 11/2010 | |
| Drospirenone; Ethinyl Estradiol; Levomefolate Calcium (PDF - 52KB) | Draft | Oral | Tablet | 3/2012 | |
| Drospirenone; Estradiol (PDF-43KB) | Final | Oral | Tablet | 21355 | 5/2008 |
| Drospirenone; Ethinyl Estradiol (PDF-21KB) | Draft | Oral | Tablet | 21676 | 3/2009 |
| 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 |
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