Drugs

Product-Specific Recommendations for Generic Drug Development: Active Ingredients starting with 'H'

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

 Halobetasol propionate (PDF - 39KB)

DraftTopicalCream199674/2016

 Halobetasol propionate (PDF - 39KB)

DraftTopicalOintment199684/2016
Haloperidol (PDF - 15KB)DraftOralTablet

71206

71207

71208

71209

71210

71211

12/2008
Homatropine Methylbromide; Hydrocodone Bitartrate (PDF - 16KB)DraftOralTablet8850812/2009
Hydralazine HCl (PDF - 21KB)DraftOralTablet

89098

89097

88467

88468

7/2008
Hydralazine HCl; Isosorbide Dinitrate (PDF - 19KB)DraftOralTablet2072712/2009
Hydrochlorothiazide (PDF - 33KB)DraftOralTablet831775/2010
Hydrochlorothiazide (PDF - 47KB)FinalOralCapsule205045/2008
Hydrochlorothiazide;Irbesartan (PDF - 45KB)RevisedDraftOralTablet207583/2012
Hydrochlorothiazide; Lisinopril (PDF - 24KB)
Revised
DraftOralTablet1988812/2012
Hydrochlorothiazide; Losartan Potassium (PDF - 113KB)RevisedDraftOralTablet2038712/2012

Hydrochlorothiazide/Metoprolol Succinate (PDF - 23KB)

Draft OralTablet, Extended Release219564/2014
Hydrochlorothiazide; Metoprolol Tartrate (PDF - 39KB)DraftOralTablet183038/2010
Hydrochlorothiazide; Moexipril HCl (PDF - 27KB) RevisedDraftOralTablet207297/2014
Hydrochlorothiazide; Olmesartan Medoxomil (PDF - 46KB)FinalOralTablet215325/2008

Hydrochlorothiazide; Quinapril Hydrochloride (PDF - 34KB)

DraftOralTablet201257/2010
Hydrochlorothiazide; Spironolactone (PDF - 16KB)DraftOralTablet1261612/2009
Hydrochlorothiazide and Telmisartan (PDF - 16KB)DraftOralTablet211627/2008

 Hydrochlorothiazide; Triamterene

 (PDF - 22KB)
Draft OralTablet191296/2013
Hydrochlorothiazide; Triamterene (PDF - 18KB)DraftOralCapsule

16042

73191

10/2008
Hydrochlorothiazide; Valsartan (PDF - 41KB)
Revised
DraftOralTablet208187/2008
Hydrocodone bitartrate; Ibuprofen (PDF - 18KB) RevisedDraftOralTablet02071612/2014

Hydrocortisone (PDF - 35KB)

DraftTopicalSolution812716/2016
Hydrocortisone (PDF - 22KB)DraftOralTablet086974/2013

Hydromorphone HCl (PDF - 44KB)

DraftOralTablet, Extended Release0212177/2014
Hydromorphone HCl (PDF - 16KB)DraftOralTablet198922/2010
Hydroxychloroquine Sulfate (PDF - 33KB)DraftOralTablet097684/2011
Hydroxyurea (PDF - 20KB)DraftOralCapsule162958/2008
Hydroxyzine HCl (PDF - 13KB)DraftOralTablet

88617

88618 

88619 

6/2010
Hydroxyzine Pamoate (PDF - 33KB)FinalOralCapsule1145910/2011
Hydroxyzine Pamoate (PDF - 33KB)FinalOralSuspension1179510/2011

 

Page Last Updated: 10/28/2016
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