Drugs

Product-Specific Guidances for Generic Drug Development: Active Ingredients starting with 'E'

Product-Specific Guidances 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 018751 3/2010

Edoxaban tosylate (PDF - 63KB)

Draft  Oral Tablet 206316 5/2017
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

Elbasvir; Grazoprevir (PDF -40KB)

Draft Oral Tablet 208261 10/2016
Eletriptan Hydrobromide (PDF - 33KB) Final Oral Tablet 21016 10/2011

Eliglustat tartrate (PDF - 39KB)

Draft Oral Capsule 205494 6/2015

Eltrombopag Olamine (PDF - 46KB)

Draft Oral Suspension 207027 10/2016
Eltrombopag Olamine (PDF -41KB) Revised Draft Oral Tablet 022291 3/2015

Eluxadoline  (PDF - 41KB)

Draft Oral Tablet 206940 4/2016

Elvitegravir (PDF - 38KB)

Draft  Oral Tablet 203093 1/2016

Empagliflozin (PDF - 23KB) 

Draft Oral Tablet 204629 6/2015

Empagliflozin; Linagliptin (PDF - 57KB)

Draft Oral Tablet 206073 4/2016

Empagliflozin and Metformin HCl (PDF - 41KB) 

Draft Oral Tablet 206111 6/2016
Emtricitabine (PDF - 38KB) Revised Final Oral Capsule 21500 8/2010

Emtricitabine; Rilpivirine hydrochloride; Tenofovir alafenamide fumarate (PDF - 25KB) Revised

Draft Oral Tablet 208351 8/2017

Emtricitabine, rilpivirine hydrochloride, tenofovir disoproxil fumarate (PDF - 42KB)

Draft  Oral Tablet 202123 3/2015

 

Emtricitabine; Tenofovir alafenamide fumarate (PDF - 39KB) Revised

 

Draft Oral Tablet 208215 8/2017

Emtricitabine; Tenofovir disoproxil fumarate (PDF - 23KB) Revised

Draft Oral Tablet 21752 5/2017
Enalapril Maleate (PDF - 22KB) Draft Oral Tablet 18998 8/2008
Enoxaparin Sodium (PDF - 42KB)  Draft Subcutaneous Injection 20164 10/2011
Entacapone (PDF - 52KB) Revised Draft Oral Tablet 20796 6/2013
Entecavir (PDF - 41KB) Final Oral Tablet 21797 5/2008

Enzalutamide (PDF - 61KB)

Draft  Oral Capsule 203415 6/2015

Epinephrine (PDF - 54KB)

Draft Intramuscular, subcutaneous Injectable 19430 12/2016
Eplerenone (PDF - 54KB) Final Oral Tablet 21437 5/2008
Eprosartan Mesylate (PDF - 16KB) Final Oral Tablet 20738 8/2017
Eprosartan Mesylate; Hydrochlorothiazide (PDF - 57KB) Draft Oral Tablet 21268 2/2008

Ergocalciferol (PDF - 46KB) Revised

Draft Oral Capsule 03444 7/2014
Erlotinib HCl (PDF - 16KB) Final Oral Tablet 21743 5/2008

Erythromycin (PDF - 23KB)

Draft  Oral Tablet, Delayed Release 62298 4/2014
Erythromycin (PDF - 40KB)  Revised  Draft  Ophthalmic Ointment 62447 10/2016
Erythromycin (PDF - 14KB) Draft Topical Solution 64187 2/2010
Erythromycin (PDF - 12KB) Draft Topical Swab 64126 2/2010

Erythromycin (PDF - 39KB)

Draft Oral Tablet 061621 1/2016

Erythromycin ethylsuccinate (PDF - 39KB)

Draft Oral Granule 050207 6/2016

Erythromycin ethylsuccinate (PDF - 39KB)

Draft Oral Tablet

061904


061905

4/2016
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

Eslicarbazepine acetate (PDF - 39KB)

Draft Oral Tablet 022416 9/2015

Esomeprazole magnesium (PDF - 69KB)

Draft Oral Capsule, Delayed Release 204655 12/2016

Esomeprazole Magnesium (PDF - 39KB) Revised

Draft Oral Tablet, Delayed Release 207920 8/2017
Esomeprazole Magnesium (PDF - 18KB)  Draft Oral Powder, Delayed Release

21957

22101

9/2015
Esomeprazole Magnesium (PDF - 55KB)  Draft Oral Capsule, Delayed Release Pellets 21153 8/2014
Esomeprazole Magnesium; Naproxen (PDF - 45KB) Draft Oral Tablets, Delayed Release 22511 3/2011

Esomeprazole Strontium (PDF - 62KB)

Draft Oral Capsule, Delayed Release 202342 7/2014
Estradiol (PDF - 33KB) Draft Oral Tablet

84500

84499

81295

12/2010

Estradiol (PDF - 155KB) Revised

Draft Transdermal Film, Extended Release 203752 10/2016
Estradiol (PDF - 146KB) Revised Draft Transdermal Film, Extended Release 19081 10/2016
Estradiol (PDF - 148KB) Revised Draft Transdermal Film, Extended Release

20375

21674

10/2016
Estradiol (PDF - 137KB) Revised Draft Transdermal Film, Extended Release 20538 10/2016
Estradiol (PDF - 54KB) Revised Draft Vaginal Cream 86069 9/2014
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) Final Oral Tablet 16320 8/2017
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 -41KB) Revised

Draft Oral Tablet 204061

21544

22262

21840

 
12/2014
Ethinyl Estradiol; Levonorgestrel (PDF - 18KB) Draft Oral Tablet

019190

019192

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

020683

3/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) Draft Oral Tablet 020860 10/2008
Ethinyl Estradiol; Norelgestromin (PDF - 142KB) Revised Draft Transdermal Film, Extended Release 200910 10/2016

Ethinyl Estradiol; Norethindrone (PDF - 22KB)

Draft Oral Tablet, Chewable 203667 7/2014
Ethinyl Estradiol; Norethindrone (PDF - 41KB)  Draft  Oral Tablet, Chewable 22573  3/2012
Ethinyl Estradiol; Norethindrone (PDF - 30KB) Revised Draft Oral Tablet

203006 

200897

9/2015
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

017355

017354

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; Norethindrone Acetate (PDF - 37KB)

Draft Oral Tablet, chewable 204654 1/2016
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

Ethiodized oil (PDF - 43KB)

Draft

 intralymphatic,
intrauterine,
selective hepatic intra-arterial

Injectable

009190

12/2016

 

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 018922 11/2013

Etodolac (PDF - 23KB)

Draft Oral Tablet

018922

11/2013
Etodolac (PDF - 34KB) Draft Oral Tablet, Extended Release 20584 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 Oral Tablet 22334 6/2012

Everolimus (PDF - 178KB)

Draft Oral Tablet 21560 6/2016
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

 

Page Last Updated: 09/07/2017
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