Drugs

Product-Specific Recommendations for Generic Drug Development: 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Econazole Nitrate (PDF - 78KB)DraftTopicalCream760753/2010
Efavirenz (PDF - 38KB)FinalOralCapsule209725/2008
Efavirenz (PDF - 45KB)FinalOralTablet213605/2008
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate (PDF - 16KB)DraftOralTablet2193710/2008
Eletriptan Hydrobromide (PDF - 33KB)FinalOralTablet2101610/2011

Eliglustat tartrate (PDF - 39KB)

DraftOralCapsule2054946/2015
Eltrombopag Olamine (PDF -41KB) RevisedDraftOralTablet0222913/2015

 Eluxadoline  (PDF - 41KB)

DraftOralTablet2069404/2016

 Elvitegravir (PDF - 38KB)

Draft OralTablet2030931/2016

 Empagliflozin (PDF - 23KB) 

DraftOralTablet2046296/2015

 Empagliflozin; Linagliptin (PDF - 57KB)

DraftOralTablet2060734/2016

 Empagliflozin and Metformin HCl (PDF - 41KB) 

DraftOralTablet2061116/2016
Emtricitabine (PDF - 38KB) RevisedFinalOralCapsule215008/2010

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

Draft OralTablet2021233/2015

 Emtricitabine; Tenofovir disoproxil fumarate (PDF - 23KB)

DraftOralTablet217526/2015
Enalapril Maleate (PDF - 22KB)DraftOralTablet189988/2008
Enoxaparin Sodium (PDF - 42KB) DraftSubcutaneousInjection2016410/2011
Entacapone (PDF - 52KB) RevisedDraftOralTablet207966/2013
Entecavir (PDF - 41KB)FinalOralTablet217975/2008

 Enzalutamide (PDF - 61KB)

Draft OralCapsule2034156/2015
Eplerenone (PDF - 54KB)FinalOralTablet214375/2008
Eprosartan Mesylate (PDF - 16KB)DraftOralTablet207387/2008
Eprosartan Mesylate; Hydrochlorothiazide (PDF - 57KB)DraftOralTablet212682/2008

Ergocalciferol (PDF - 46KB) Revised

DraftOralCapsule034447/2014
Erlotinib HCl (PDF - 16KB) FinalOralTablet217435/2008

Erythromycin (PDF - 23KB)

Draft OralTablet, Delayed Release622984/2014
 Erythromycin (PDF - 40KB)  Revised Draft OphthalmicOintment6244710/2016
Erythromycin (PDF - 14KB)DraftTopicalSolution641872/2010
Erythromycin (PDF - 12KB)DraftTopicalSwab641262/2010

 Erythromycin (PDF - 39KB)

DraftOralTablet0616211/2016

 Erythromycin ethylsuccinate (PDF - 39KB)

DraftOralGranule0502076/2016

 Erythromycin ethylsuccinate (PDF - 39KB)

DraftOralTablet

061904


061905

4/2016
Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl (PDF - 34KB)DraftOralGranule627595/2010
Escitalopram Oxalate (PDF - 16KB)DraftOralCapsule776609/2008
Escitalopram Oxalate (PDF - 45KB)FinalOralTablet213235/2008

Eslicarbazepine acetate (PDF - 39KB)

DraftOralTablet0224169/2015
Esomeprazole Magnesium (PDF - 18KB) DraftOralPowder, Delayed Release

21957

22101

9/2015
Esomeprazole Magnesium (PDF - 55KB) DraftOralCapsule, Delayed Release Pellets211538/2014
Esomeprazole Magnesium; Naproxen (PDF - 45KB)DraftOralTablets, Delayed Release225113/2011

Esomeprazole Strontium (PDF - 62KB)

DraftOralCapsule, Delayed Release2023427/2014
Estradiol (PDF - 33KB)DraftOralTablet

84500

84499

81295

12/2010

Estradiol (PDF - 155KB) Revised

DraftTransdermalFilm, Extended Release20375210/2016
Estradiol (PDF - 146KB) RevisedDraftTransdermalFilm, Extended Release1908110/2016
Estradiol (PDF - 148KB) RevisedDraftTransdermalFilm, Extended Release

20375

21674

10/2016
Estradiol (PDF - 137KB) RevisedDraftTransdermalFilm, Extended Release2053810/2016
Estradiol (PDF - 54KB) RevisedDraftVaginalCream860699/2014
Estradiol (PDF - 69KB)  RevisedDraftVaginalTablet209083/2011
Estramustine Phosphate Sodium (PDF - 24KB)Draft OralCapsule0180454/2013
Estrogens, Conjugated Synthetic A (PDF - 17KB)DraftOralTablet209924/2010
Estrogens, Esterified (PDF - 19KB) RevisedDraftOralTablet84948
84949
84950
84951
 
9/2012
Eszopiclone (PDF - 18KB)DraftOralTablet214761/2008
Ethacrynic Acid (PDF - 32KB)DraftOralTablet1609212/2010
Ethambutol HCl (PDF - 18KB)DraftOralTablet163201/2008
Ethinyl Estradiol; Ethynodiol Diacetate (PDF - 20KB)
Revised
DraftOralTablet

72723

72721

12/2009
Ethinyl Estradiol; Etonogestrel (PDF - 22KB)Draft VaginalRing211874/2013

Ethinyl Estradiol; Levonorgestrel (PDF -41KB) Revised

DraftOralTablet204061

21544

22262

21840

 
12/2014
Ethinyl Estradiol; Levonorgestrel (PDF - 18KB)DraftOralTablet7453811/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB)DraftOralTablet218644/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB)DraftOralTablet187823/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB)DraftOralTablet766253/2009
Ethinyl Estradiol; Levonorgestrel (PDF - 16KB) DraftOralTablet7768110/2008
Ethinyl Estradiol; Norelgestromin (PDF - 142KB) RevisedDraftTransdermalFilm, Extended Release20091010/2016

Ethinyl Estradiol; Norethindrone (PDF - 22KB)

DraftOralTablet, Chewable2036677/2014
Ethinyl Estradiol; Norethindrone (PDF - 41KB) Draft OralTablet, Chewable22573 3/2012
Ethinyl Estradiol; Norethindrone (PDF - 30KB) RevisedDraftOralTablet

203006 

200897

9/2015
Ethinyl Estradiol; Norethindrone (PDF - 16KB)DraftOralTablet1897711/2009
Ethinyl Estradiol; Norethindrone (PDF - 22KB) RevisedDraftOralTablet, Chewable214907/2010
Ethinyl Estradiol; Norethindrone (PDF - 43KB)
Revised
DraftOralTablet

18985

17735

17919

12/2010
Ethinyl Estradiol; Norethindrone Acetate (PDF - 39KB)DraftOralTablet225016/2011
Ethinyl Estradiol; Norethindrone Acetate (PDF - 18KB)DraftOralTablet

75548

75647

21871

10/2009
Ethinyl Estradiol; Norethindrone Acetate (PDF - 23KB)DraftOralTablet209073/2009
Ethinyl Estradiol; Norethindrone Acetate (PDF - 16KB)DraftOralTablet201307/2008
Ethinyl Estradiol; Norethindrone Acetate (PDF - 16KB)DraftOralTablet210657/2008

 Ethinyl Estradiol; Norethindrone Acetate (PDF - 37KB)

DraftOralTablet, chewable2046541/2016
Ethinyl Estradiol; Norgestimate (PDF - 21 KB)DraftOralTablet

19653

19697

21241

12/2009
Ethinyl Estradiol; Norgestrel (PDF - 20KB)DraftOralTablet

75406

75288

10/2009

 

Ethionamide (PDF - 22KB) 

DraftOralTablet

13026

4/2013
Ethosuximide (PDF - 15KB)DraftOralCapsule123807/2008
Etidronate Disodium (PDF - 45KB)FinalOralTablet178315/2008

Etodolac (PDF - 23KB)

 Draft OralCapsule7507811/2013

Etodolac (PDF - 23KB)

DraftOralTablet

75074

11/2013
Etodolac (PDF - 34KB)DraftOralTablet, Extended Release756657/2010
Etoposide (PDF - 41KB)DraftOralCapsule756358/2010
Etravirine (PDF - 34KB) Revised DraftOralTablet221879/2012
Everolimus (PDF - 34KB)RevisedDraftOralTablet223346/2012

 Everolimus (PDF - 178KB)

DraftOralTablet215606/2016
Exemestane (PDF - 46KB)FinalOralTablet207535/2008
Ezetimibe (PDF - 16KB)DraftOralTablet2144510/2008
Ezetimibe; Simvastatin (PDF - 17KB)DraftOralTablet216879/2008

 

Ezogabine (PDF - 21KB)

Draft OralTablet223454/2013

 

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