• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'E'

 

 

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
Econazole Nitrate (PDF - 78KB) Draft Topical Cream 76075 3/2010
Efavirenz (PDF - 38KB) Final Oral Capsule 20972 5/2008
Efavirenz (PDF - 45KB) Final Oral Tablet 21360 5/2008
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate (PDF - 16KB) Draft Oral Tablet 21937 10/2008
Eletriptan Hydrobromide (PDF - 33KB) Final Oral Tablet 21016 10/2011
Emtricitabine (PDF - 38KB) Revised Final Oral Capsule 21500 8/2010
Enalapril Maleate (PDF - 22KB) Draft Oral Tablet 18998 8/2008
Enoxaparin Sodium (PDF - 42KB)  Draft Subcutaneous Injection 20164 10/2011
Entacapone (PDF - 52KB) Revised Final Oral Tablet 20796 6/2013
Entecavir (PDF - 41KB) Final Oral Tablet 21797 5/2008
Eplerenone (PDF - 54KB) Final Oral Tablet 21437 5/2008
Eprosartan Mesylate (PDF - 16KB) Draft Oral Tablet 20738 7/2008
Eprosartan Mesylate; Hydrochlorothiazide (PDF - 57KB) Draft Oral Tablet 21268 2/2008

Ergocalciferol (PDF - 46KB)

Draft Oral Capsule 03444 11/2010
Erlotinib HCl (PDF - 16KB) Final Oral Tablet 21743 2/2008
 Erythromycin (PDF - 28KB)  Draft  Ophthalmic Ointment 62447 6/2012
Erythromycin (PDF - 14KB) Draft Topical Solution 64187 2/2010
Erythromycin (PDF - 12KB) Draft Topical Swab 64126 2/2010
Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl (PDF - 34KB) Draft Oral Granule 62759 5/2010
Escitalopram Oxalate (PDF - 16KB) Draft Oral Capsule 77660 9/2008
Escitalopram Oxalate (PDF - 45KB) Final Oral Tablet 21323 5/2008
Esomeprazole Magnesium (PDF - 18KB) Draft Oral Powder, Delayed Release

21957

22101

2/2010
Esomeprazole Magnesium (PDF - 55KB) Revised Final Oral Capsule, Delayed Release Pellets 21153 3/2011
Esomeprazole Magnesium; Naproxen (PDF - 45KB) Draft Oral Tablets, Delayed Release 22511 3/2011
Estradiol (PDF - 33KB) Draft Oral Tablet

84500

84499

81295

12/2010
Estradiol (PDF - 466KB) Draft Transdermal Film, Extended Release 19081 11/2010
Estradiol (PDF - 405KB) Draft Transdermal Film, Extended Release

20375

21674

11/2010
Estradiol (PDF - 437KB) Draft Transdermal Film, Extended Release 20538 11/2010
Estradiol (PDF - 68KB) Draft Vaginal Cream 86069 8/2009
Estradiol (PDF - 69KB) Revised Draft Vaginal Tablet 20908 3/2011
Estramustine Phosphate Sodium (PDF - 24KB) Draft  Oral Capsule 018045 4/2013
Estrogens, Conjugated Synthetic A (PDF - 17KB) Draft Oral Tablet 20992 4/2010
Estrogens, Esterified (PDF - 19KB)Revised Draft Oral Tablet 84948
84949
84950
84951
 
9/2012
Eszopiclone (PDF - 18KB) Draft Oral Tablet 21476 1/2008
Ethacrynic Acid (PDF - 32KB) Draft Oral Tablet 16092 12/2010
Ethambutol HCl (PDF - 18KB) Draft Oral Tablet 16320 1/2008
Ethinyl Estradiol; Ethynodiol Diacetate (PDF - 20KB)
Revised
Draft Oral Tablet

72723

72721

12/2009
Ethinyl Estradiol; Etonogestrel (PDF - 22KB) Draft  Vaginal Ring 21187 4/2013
Ethinyl Estradiol; Levonorgestrel (PDF - 18KB) Draft Oral Tablet 74538 11/2009
Ethinyl Estradiol; Levonorgestrel(PDF - 20KB) Draft Oral Tablet

21544

22262

21840

11/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) Draft Oral Tablet 21864 4/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) Draft Oral Tablet 18782 3/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) Draft Oral Tablet 76625 3/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) Draft Oral Tablet 77681 10/2008
Ethinyl Estradiol; Norelgestromin (PDF - 130KB) Draft Transdermal Film, Extended Release 21180 5/2009
Ethinyl Estradiol; Norethindrone (PDF - 41KB)  Draft  Oral Tablet, Chewable 22573  3/2012
Ethinyl Estradiol; Norethindrone (PDF - 30KB) Draft Oral Tablet

17716 

17576

2/2010
Ethinyl Estradiol; Norethindrone (PDF - 16KB) Draft Oral Tablet 18977 11/2009
Ethinyl Estradiol; Norethindrone (PDF - 22KB) Revised Draft Oral Tablet, Chewable 21490 7/2010
Ethinyl Estradiol; Norethindrone (PDF - 43KB)
Revised
Draft Oral Tablet

18985

17735

17919

12/2010
Ethinyl Estradiol; Norethindrone Acetate (PDF - 39KB) Draft Oral Tablet 22501 6/2011
Ethinyl Estradiol; Norethindrone Acetate (PDF - 18KB) Draft Oral Tablet

17355

17875

17354

17876

21871

10/2009
Ethinyl Estradiol; Norethindrone Acetate (PDF - 23KB) Draft Oral Tablet 20907 3/2009
Ethinyl Estradiol; Norethindrone Acetate (PDF - 16KB) Draft Oral Tablet 20130 7/2008
Ethinyl Estradiol; Norethindrone Acetate (PDF - 16KB) Draft Oral Tablet 21065 7/2008
Ethinyl Estradiol; Norgestimate (PDF - 21 KB) Draft Oral Tablet

19653

19697

21241

12/2009
Ethinyl Estradiol; Norgestrel (PDF - 20KB) Draft Oral Tablet

75406

75288

10/2009

 

Ethionamide (PDF - 22KB) 

Draft Oral Tablet

13026

4/2013
Ethosuximide (PDF - 15KB) Draft Oral Capsule 12380 7/2008
Etidronate Disodium (PDF - 45KB) Final Oral Tablet 17831 5/2008

Etodolac (PDF - 23KB)

 Draft  Oral Capsule 75078 11/2013

Etodolac (PDF - 23KB)

Draft Oral Tablet

75074

11/2013
Etodolac (PDF - 34KB) Draft Oral Tablet, Extended Release 75665 7/2010
Etoposide (PDF - 41KB) Draft Oral Capsule 75635 8/2010
Etravirine (PDF - 34KB) Revised  Draft Oral Tablet 22187 9/2012
Everolimus (PDF - 34KB)Revised Draft Tablets Oral 22334 6/2012
Exemestane (PDF - 46KB) Final Oral Tablet 20753 5/2008
Ezetimibe (PDF - 16KB) Draft Oral Tablet 21445 10/2008
Ezetimibe; Simvastatin (PDF - 17KB) Draft Oral Tablet 21687 9/2008

 

Ezogabine (PDF - 21KB)

Draft  Oral Tablet 22345 4/2013