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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 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Ibandronate Sodium (PDF - 17KB)FinalOralTablet214555/2008

Ibuprofen (PDF - 32KB)

DraftOralCapsule2147211/2010
Ibuprofen (PDF - 17KB)DraftOralTablet756823/2010
Ibuprofen (PDF - 16KB)DraftOralTablet190123/2010
Ibuprofen (PDF - 16KB)
Revised
DraftOralSuspension205167/2009
Ibuprofen (PDF - 16KB)DraftOralSuspension, Drops2060310/2008

Ibuprofen; Phenylephrine Hydrochloride

(PDF - 33KB)

 DraftOralTablet

22565

10/2011
Ibuprofen; Pseudoephedrine HCl (PDF - 17KB)
 
DraftOralSuspension211288/2007
Icosapent Ethyl (PDF - 83KB) RevisedDraftOralCapsule2020572/2014

Iloperidone (PDF - 33KB)

DraftOralTablet2219211/2010
Imatinib Mesylate (PDF - 31KB)RevisedFinalOralTablet215884/2013
Imipramine Pamoate (PDF - 33KB)DraftOralCapsule170902/2011
Imiquimod (PDF - 164KB) DraftTopicalCream 2.5%2248311/2011
Imiquimod (PDF - 171KB)DraftTopicalCream224832/2011
Imiquimod (PDF - 163KB)DraftTopicalCream207232/2010
Indapamide (PDF - 15KB)DraftOralTablet744617/2008
Indinavir Sulfate(PDF - 48KB) FinalOralCapsule206855/2008
Indomethacin (PDF - 28KB)DraftOralCapsules

70624 

18858

2/2010
Indomethacin (PDF - 27KB)DraftOralCapsule, Extended Release744642/2010
Irbesartan (PDF - 25KB)FinalOralTablet207575/2008
Iron Sucrose (PDF - 33KB) RevisedDraftIntravenousInjection2113511/2013
Isoniazid (PDF - 15KB)DraftOralTablet086787/2008
Isosorbide Mononitrate (PDF - 127KB)FinalOralTablet, Extended Release751555/2008
Isotretinoin (PDF - 29KB) RevisedDraftOralCapsule761356/2013
Isradipine (PDF - 127KB)FinalOralCapsule773175/2008
Isradipine (PDF - 53KB)FinalOralTablet, Extended Release203365/2008
 Itraconazole (PDF - 40KB) Draft OralTablet224846/2012
Itraconazole (PDF - 32KB)DraftOralCapsule200835/2007
Ivermectin (PDF - 23KB)DraftOralTablet507423/2012