Drugs

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

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

Halcinonide (PDF - 35KB)

Draft Topical Cream 017556 12/2016

Halobetasol Propionate (PDF - 36KB)

Draft Topical Lotion 208183 10/2016

Halobetasol propionate (PDF - 39KB)

Draft Topical Cream 19967 4/2016

Halobetasol propionate (PDF - 39KB)

Draft Topical Ointment 19968 4/2016
Haloperidol (PDF - 15KB) Draft Oral Tablet

015921

12/2008
Homatropine Methylbromide; Hydrocodone Bitartrate (PDF - 16KB) Draft Oral Tablet 005213 12/2009
Hydralazine HCl (PDF - 21KB) Draft Oral Tablet

008303

7/2008
Hydralazine HCl; Isosorbide Dinitrate (PDF - 19KB) Draft Oral Tablet 20727 12/2009
Hydrochlorothiazide (PDF - 33KB) Draft Oral Tablet 11835 5/2010
Hydrochlorothiazide (PDF - 47KB) Final Oral Capsule 20504 5/2008
Hydrochlorothiazide;Irbesartan (PDF - 45KB)Revised Draft Oral Tablet 20758 3/2012
Hydrochlorothiazide; Lisinopril (PDF - 24KB)
Revised
Draft Oral Tablet 19888 12/2012
Hydrochlorothiazide; Losartan Potassium (PDF - 113KB) Final Oral Tablet 20387 8/2017

Hydrochlorothiazide/Metoprolol Succinate (PDF - 23KB)

Draft  Oral Tablet, Extended Release 21956 4/2014
Hydrochlorothiazide; Metoprolol Tartrate (PDF - 39KB) Draft Oral Tablet 18303 8/2010
Hydrochlorothiazide; Moexipril HCl (PDF - 27KB) Revised Draft Oral Tablet 20729 7/2014
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) Final Oral Capsule

16042

73191

8/2017
Hydrochlorothiazide; Valsartan (PDF - 41KB)
Final Oral Tablet 20818 8/2017

Hydrocodone bitartrate (PDF - 55KB)

Draft Oral Capsule, Extended Release 202880 10/2016

Hydrocodone bitartrate (PDF - 78KB)

Draft Oral Tablet, Extended Release 206627 10/2016
Hydrocodone bitartrate; Ibuprofen (PDF - 18KB) Final Oral Tablet 020716 8/2017

Hydrocortisone (PDF - 37KB)

Draft Topical Cream 089414 5/2017

Hydrocortisone (PDF - 35KB)

Draft Topical Solution 81271 6/2016
Hydrocortisone (PDF - 22KB) Final Oral Tablet 08697 8/2017

Hydrocortisone butyrate (PDF - 35KB) 

Draft Topical Lotion 022076 5/2017

Hydrocortisone valerate (PDF - 38KB)/p>

Draft Topical Ointment 018726 10/2016

Hydromorphone HCl (PDF - 44KB)

Draft Oral Tablet, Extended Release 021217 7/2014
Hydromorphone HCl (PDF - 16KB) Final Oral Tablet 19892 8/2017
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

 

Page Last Updated: 09/08/2017
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