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U.S. Department of Health and Human Services

Drugs

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Bioequivalence Recommendations for Specific Products: 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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
Haloperidol (PDF - 15KB) Draft Oral Tablet

71206

71207

71208

71209

71210

71211

12/2008
Homatropine Methylbromide; Hydrocodone Bitartrate (PDF - 16KB) Draft Oral Tablet 88508 12/2009
Hydralazine HCl (PDF - 21KB) Draft Oral Tablet

89098

89097

88467

88468

7/2008
Hydralazine HCl; Isosorbide Dinitrate (PDF - 19KB) Draft Oral Tablet 20727 12/2009
Hydrochlorothiazide (PDF - 33KB) Draft Oral Tablet 83177 5/2010
Hydrochlorothiazide (PDF - 47KB) Final Oral Capsule 20504 5/2008
Hydrochlorothiazide;Irbesartan (PDF - 45KB)Revised Final Oral Tablet 20758 3/2012
Hydrochlorothiazide; Lisinopril (PDF - 24KB)
Revised
Draft Oral Tablet 19888 12/2012
Hydrochlorothiazide; Losartan Potassium (PDF - 113KB)Revised Draft Oral Tablet 20387 12/2012
Hydrochlorothiazide; Metoprolol Tartrate (PDF - 39KB) Draft Oral Tablet 18303 8/2010
Hydrochlorothiazide; Moexipril HCl (PDF - 27KB) Draft Oral Tablet 20729 12/2009
Hydrochlorothiazide; Olmesartan Medoxomil (PDF - 46KB) Final Oral Tablet 21532 5/2008

Hydrochlorothiazide; Quinapril Hydrochloride (PDF - 34KB)

Draft Oral Tablet 20125 7/2010
Hydrochlorothiazide; Spironolactone (PDF - 16KB) Draft Oral Tablet 12616 12/2009
Hydrochlorothiazide and Telmisartan (PDF - 16KB) Draft Oral Tablet 21162 7/2008

 Hydrochlorothiazide; Triamterene

 (PDF - 22KB)
Draft  Oral Tablet 19129 6/2013
Hydrochlorothiazide; Triamterene (PDF - 18KB) Draft Oral Capsule

16042

73191

10/2008
Hydrochlorothiazide; Valsartan (PDF - 41KB)
Revised
Draft Oral Tablet 20818 7/2008
Hydrocodone Bitartrate; Ibuprofen (PDF - 16KB) Draft Oral Tablet

20716

76642

12/2009
Hydrocortisone (PDF - 22KB) Draft Oral Tablet 08697 4/2013
Hydromorphone HCl (PDF - 16KB) Draft Oral Tablet 19892 2/2010
Hydroxychloroquine Sulfate (PDF - 33KB) Draft Oral Tablet 09768 4/2011
Hydroxyurea (PDF - 20KB) Draft Oral Capsule 16295 8/2008
Hydroxyzine HCl (PDF - 13KB) Draft Oral Tablet

88617

88618 

88619 

6/2010
Hydroxyzine Pamoate (PDF - 33KB) Final Oral Capsule 11459 10/2011
Hydroxyzine Pamoate (PDF - 33KB) Final Oral Suspension 11795 10/2011