Drugs

Product-Specific Recommendations for Generic Drug Development: 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
 

Ibrutinib (PDF - 23KB)

DraftOralCapsule2055523/2015

 Ibuprofen (PDF - 39KB)

DraftOralCapsule0204023/2015

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
Ibuprofen sodium  (PDF - 22KB)DraftOralTablet20180312/2014
Icosapent Ethyl (PDF - 83KB) RevisedDraftOralCapsule2020572/2014

Iloperidone (PDF - 33KB)

DraftOralTablet2219211/2010
Imatinib Mesylate (PDF - 31KB)RevisedFinalOralTablet215887/2014
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

Ipratropium bromide (PDF - 95KB)

DraftInhalationAerosol, metered0215273/2015
Irbesartan (PDF - 25KB)FinalOralTablet207575/2008
Iron Sucrose (PDF - 33KB) RevisedDraftIntravenousInjection2113511/2013
Isoniazid (PDF - 15KB)DraftOralTablet086787/2008

Isosorbide dinitrate  (PDF - 59KB)

DraftOralTablet0120933/2015

Isosorbide dinitrate (PDF - 59KB)

DraftOralTablet0879463/2015
Isosorbide Mononitrate (PDF - 127KB)FinalOralTablet, Extended Release751555/2008

Isotretinoin (PDF - 45KB)

Draft OralCapsule0219513/2015
Isotretinoin (PDF - 29KB) RevisedDraftOralCapsule761353/2015
Isradipine (PDF - 127KB)FinalOralCapsule773175/2008
Isradipine (PDF - 53KB)FinalOralTablet, Extended Release203365/2008
Itraconazole (PDF - 40KB) Draft OralTablet224846/2012
Itraconazole (PDF - 32KB)DraftOralCapsule200835/2007

Ivacaftor (PDF - 39KB)

DraftOralTablet2031883/2015
Ivermectin (PDF - 23KB)DraftOralTablet507423/2012

 

Page Last Updated: 06/15/2015
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