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)
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
 

Ibrutinib (PDF - 23KB)

Draft Oral Capsule 205552 3/2015

 Ibuprofen (PDF - 39KB)

Draft Oral Capsule 020402 3/2015

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
Ibuprofen sodium  (PDF - 22KB) Draft Oral Tablet 201803 12/2014
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 - 38KB)

Draft Oral Capsule 204768 6/2015
Indomethacin (PDF - 28KB) Draft Oral Capsules

70624 

18858

2/2010
Indomethacin (PDF - 27KB) Draft Oral Capsule, Extended Release 74464 2/2010

Ipratropium bromide (PDF - 95KB)

Draft Inhalation Aerosol, metered 021527 3/2015
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 dinitrate  (PDF - 59KB)

Draft Oral Tablet 012093 3/2015

Isosorbide dinitrate (PDF - 59KB)

Draft Oral Tablet 087946 3/2015
Isosorbide Mononitrate (PDF - 127KB) Final Oral Tablet, Extended Release 75155 5/2008

Isotretinoin (PDF - 45KB)

Draft  Oral Capsule 021951 3/2015
Isotretinoin (PDF - 29KB) Revised Draft Oral Capsule 76135 3/2015
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

Ivacaftor (PDF - 39KB)

Draft Oral Tablet 203188 3/2015
Ivermectin (PDF - 23KB) Draft Oral Tablet 50742 3/2012

 

Page Last Updated: 09/02/2015
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