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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 I'

 

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
Ibandronate Sodium (PDF - 17KB) Final Oral Tablet 21455 5/2008

Ibuprofen (PDF - 32KB)

Draft Oral Capsule 21472 11/2010
Ibuprofen (PDF - 17KB) Draft Oral Tablet 75682 3/2010
Ibuprofen (PDF - 16KB) Draft Oral Tablet 19012 3/2010
Ibuprofen (PDF - 16KB)
Revised
Draft Oral Suspension 20516 7/2009
Ibuprofen (PDF - 16KB) Draft Oral Suspension, Drops 20603 10/2008

Ibuprofen; Phenylephrine Hydrochloride

(PDF - 33KB)

 Draft Oral Tablet

22565

10/2011
Ibuprofen; Pseudoephedrine HCl (PDF - 17KB)
 
Draft Oral Suspension 21128 8/2007
Icosapent Ethyl (PDF - 83KB) Revised Draft Oral Capsule 202057 2/2014

Iloperidone (PDF - 33KB)

Draft Oral Tablet 22192 11/2010
Imatinib Mesylate (PDF - 31KB)Revised Final Oral Tablet 21588 7/2014
Imipramine Pamoate (PDF - 33KB) Draft Oral Capsule 17090 2/2011
Imiquimod (PDF - 164KB)  Draft Topical Cream 2.5% 22483 11/2011
Imiquimod (PDF - 171KB) Draft Topical Cream 22483 2/2011
Imiquimod (PDF - 163KB) Draft Topical Cream 20723 2/2010
Indapamide (PDF - 15KB) Draft Oral Tablet 74461 7/2008
Indinavir Sulfate(PDF - 48KB) Final Oral Capsule 20685 5/2008
Indomethacin (PDF - 28KB) Draft Oral Capsules

70624 

18858

2/2010
Indomethacin (PDF - 27KB) Draft Oral Capsule, Extended Release 74464 2/2010
Irbesartan (PDF - 25KB) Final Oral Tablet 20757 5/2008
Iron Sucrose (PDF - 33KB) Revised Draft Intravenous Injection 21135 11/2013
Isoniazid (PDF - 15KB) Draft Oral Tablet 08678 7/2008
Isosorbide Mononitrate (PDF - 127KB) Final Oral Tablet, Extended Release 75155 5/2008
Isotretinoin (PDF - 29KB) Revised Draft Oral Capsule 76135 6/2013
Isradipine (PDF - 127KB) Final Oral Capsule 77317 5/2008
Isradipine (PDF - 53KB) Final Oral Tablet, Extended Release 20336 5/2008
 Itraconazole (PDF - 40KB)  Draft  Oral Tablet 22484 6/2012
Itraconazole (PDF - 32KB) Draft Oral Capsule 20083 5/2007
Ivermectin (PDF - 23KB) Draft Oral Tablet 50742 3/2012