Drugs

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

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
Famciclovir (PDF - 21KB) Draft Oral Tablet 20363 8/2008
Famotidine (PDF - 16KB) Draft Oral Suspension 19527 12/2008
Famotidine (PDF - 41KB) Final Oral Tablet, Orally Disintegrating 21712 5/2008
Famotidine (PDF - 47KB) Final Oral Tablet 19462
20325
5/2008
Famotidine; Ibuprofen (PDF - 41KB)  Draft  Oral Tablet 22519 6/2012
Febuxostat (PDF - 26KB) Draft Oral Tablet 21856 2/2010
Felbamate (PDF - 19KB) Revised Draft Oral Tablet 20189 2/2010
Felbamate (PDF - 19KB) Revised Draft Oral Suspension 20189 2/2010
Felodipine (PDF - 31KB) Draft Oral Tablet, Extended Release 019834 12/2009

Fenofibrate (PDF - 39KB)

Draft Oral Capsule 021695 12/2016
Fenofibrate (PDF - 39KB) Draft Oral Tablet 021203 3/2012
Fenofibrate (PDF - 26KB) Draft Oral Capsule 019304 2/2010
Fenofibrate (PDF - 16KB) Draft Oral Tablet 22118 9/2008
Fenofibrate (PDF - 18KB) Draft Oral Capsule 21612 2/2008
Fenofibrate (PDF - 51KB) Final Oral Capsule 21695 5/2008
Fenofibrate (PDF - 50KB) Final Oral Tablet 21656 5/2008
Fenofibrate (PDF - 16KB) Draft Oral Tablet 21350 10/2008
Fenofibric Acid (PDF - 30KB) Draft Oral Tablet 22418 8/2010
Fenoprofen Calcium (PDF - 28KB) Final Oral Capsule 17604 10/2011

Fentanyl (PDF - 39KB)

Draft Sublingual Spray 202788 6/2015

Fentanyl (PDF - 105KB)  Revised

 

Draft Transdermal Film, Extended Release 19813 10/2016

Fentanyl Citrate (PDF - 29KB)

Draft Nasal Spray, Metered 22569 4/2014
Fentanyl Citrate (PDF - 19KB) Draft Sublingual Tablet 22510 9/2012
Fentanyl Citrate (PDF - 19KB) Draft Transmucosal/Oral Troche; Lozenge 20747 2/2010
Fentanyl Citrate (PDF - 18KB) Revised Draft Oral Tablet, Buccal 21947 6/2013

Ferric carboxymaltose (PDF - 59KB)

Draft Intravenous Injectable 203565 4/2016

Ferric citrate (PDF - 29KB)

Draft Oral Tablet 205874 9/2015
Ferumoxytol (PDF -33KB) Draft  Intravenous Injection 22180 12/2012

Fesoterodine Fumarate (PDF - 47KB)

Draft Oral Tablet, Extended Release 22030 11/2010
Fexofenadine HCl (PDF - 16KB) Draft Oral Suspension 21963 12/2008
Fexofenadine HCl (PDF - 20KB) Draft Oral Tablet, Orally Disintegrating 21909 8/2008
Fexofenadine HCl (PDF - 16KB)
Revised
Draft Oral Capsule 20625 9/2008
Fexofenadine HCl (PDF - 16KB)
Revised
Draft Oral Tablet 020872 7/2009
Fexofenadine HCl; Pseudoephedrine HCl (PDF - 18KB) Draft Oral Tablet, Extended Release

20786

21704

10/2009

Fidaxomicin (PDF -26KB)

Draft Oral Tablet 201699 8/2016
Finasteride (PDF - 35KB) Draft Oral Tablet

20180

20788

1/2011
Fingolimod (PDF - 36KB) Revised Draft Oral Capsule 22527 5/2017
Flavoxate HCl (PDF - 31KB) Draft Oral Tablet 16769 5/2007
Flecainide Acetate (PDF - 17KB) Draft Oral Tablet 018830 2/2010
Flibanserin (PDF - 41KB) Draft Oral Tablet 22526 6/2016
Fluconazole (PDF - 45KB) Final Oral Tablet 19949 5/2008
Flucytosine (PDF - 33KB) Draft Oral Capsule 17001 7/2010
Fludarabine Phosphate (PDF - 33KB) Draft Oral Tablet 22273  3/2012
Fludrocortisone Acetate (PDF - 28KB) Final Oral Tablet 010060 10/2011

Fluocinonide (PDF - 35KB)

Draft Topical Cream 21758 12/2016

Fluocinonide (PDF -38KB)

Draft Topical Gel 017373 6/2016

Fluocinonide (PDF - 38KB)

Draft  Topical Ointment 016909 6/2016

Fluocinolone acetonide, hydroquinone, and tretinoin (PDF - 110KB)

Draft Topical Cream 21112 3/2015
Fluorouracil (PDF - 176KB) Draft Topical Cream 16988 3/2011
Fluorouracil (PDF - 33KB) Draft Topical Solution, 5% 16831 6/2011
Fluorouracil (PDF - 33KB) Draft Topical Solution, 2% 16831 6/2011
Fluorouracil (PDF - 168KB) Draft Topical Cream 20985 7/2014
Fluorouracil (PDF - 41KB) Draft Topical Cream 16831 6/2010

Fluoxetine HCl (PDF - 59KB)

Draft Oral Tablet 202133 12/2016
Fluoxetine HCl (PDF - 33KB) Draft Oral Tablet 21860 2/2011
Fluoxetine HCl (PDF - 33KB) Draft Oral Tablet 020974 2/2011
Fluoxetine HCl (PDF - 78KB) Draft Oral Capsule, Delayed Release 21235 8/2010

Fluoxetine HCl (PDF - 22KB)

Draft  Oral Capsule 18936 6/2013
Fluoxetine HCl;Olanzapine(PDF - 16KB) Revised Draft Oral Capsule 21520 7/2009

Fluphenazine HCl (PDF - 41KB)

Draft Oral Tablet 089804 7/2017

Flurandrenolide (PDF -38KB)

Draft Topical Lotion 013790 1/2016
Flutamide (PDF - 23KB) Draft Oral Capsule 075780 4/2013

Fluticasone Furoate (PDF - 101KB)

Draft Inhalation Powder 205625 4/2016

Fluticasone Furoate; Vilanterol Trifenatate (PDF - 108KB)

Draft Inhalation Powder 204275 4/2016

Fluticasone propionate (PDF - 30KB)

Draft Topical Ointment 19957 10/2016

Fluticasone propionate (PDF - 197KB)

Draft Nasal Spray, metered 020121 9/2015

Fluticasone propionate  (PDF - 39KB)

Draft  Nasal Spray, metered 205434  9/2015
Fluticasone Propionate (PDF - 35KB) Draft Topical Cream 19958 2/2011

Fluticasone Propionate; Salmeterol Xinafoate (PDF - 114KB)

Draft  Inhalation Powder 21077 9/2013
Fluvastatin Sodium (PDF - 18KB) Draft Oral Capsule 20261 1/2008
Fluvastatin Sodium (PDF - 19KB) Draft Oral Tablet, Extended Release 21192 1/2008
Fluvoxamine Maleate (PDF - 36KB) Draft Oral Capsule, Extended Release 22033 2/2011

Formoterol fumarate (PDF - 99KB)

Draft Inhalation Powder 020831 9/2015

Formoterol fumarate; Mometasone furoate  (PDF - 99KB)

Draft Inhalation Aerosol, metered 022518 1/2016
Fosamprenavir Calcium (PDF - 18KB) Draft Oral Suspension 22116 11/2007
Fosamprenavir Calcium (PDF - 45KB) Final Oral Tablet 21548 5/2008

Fosfomycin Tromethamine (PDF - 20KB)

Draft Oral Suspension 50717 7/2014
Fosinopril Sodium (PDF - 58KB) Draft Oral Tablet 19915 5/2008
Fosinopril Sodium; Hydrochlorothiazide (PDF - 16KB)
Revised
Draft Oral Tablet 20286 9/2008
Frovatriptan Succinate (PDF - 16KB) Draft Oral Tablet 21006 10/2008
Fulvestrant (PDF - 33KB) Draft Injection, Intramuscular Solution 21344  3/2012
Furosemide (PDF - 34KB) Draft Oral Tablet 16273 9/2010

 

Page Last Updated: 09/08/2017
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