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U.S. Department of Health and Human Services

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'F'

 

 

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
Famciclovir (PDF - 21KB)DraftOralTablet203638/2008
Famotidine (PDF - 16KB)DraftOralSuspension1952712/2008
Famotidine (PDF - 41KB)FinalOralTablet, Orally Disintegrating217125/2008
Famotidine (PDF - 47KB)FinalOralTablet19462
20325
5/2008
 Famotidine; Ibuprofen (PDF - 41KB) Draft OralTablet225196/2012
Febuxostat (PDF - 26KB)DraftOralTablet218562/2010
Felbamate (PDF - 19KB)RevisedDraftOralTablet201892/2010
Felbamate (PDF - 19KB)RevisedDraftOralSuspension201892/2010
Felodipine (PDF - 31KB)DraftOralTablet, Extended Release7885512/2009
Fenofibrate (PDF - 39KB)DraftOralTablet764333/2012
Fenofibrate (PDF - 26KB)DraftOralCapsule757532/2010
Fenofibrate (PDF - 16KB)DraftOralTablet221189/2008
Fenofibrate (PDF - 18KB)DraftOralCapsule216122/2008
Fenofibrate (PDF - 51KB)FinalOralCapsule216955/2008
Fenofibrate (PDF - 50KB)FinalOralTablet216565/2008
Fenofibrate (PDF - 16KB)DraftOralTablet2135010/2008
Fenofibric Acid (PDF - 30KB)DraftOralTablet224188/2010
Fenoprofen Calcium (PDF - 28KB)FinalOralCapsule1760410/2011

Fentanyl (PDF - 105KB)

Revised

DraftTransdermalFilm, Extended Release198132/2010

Fentanyl Citrate (PDF - 29KB)

DraftNasalSpray, Metered225694/2014
Fentanyl Citrate (PDF - 19KB)DraftSublingualTablet225109/2012
Fentanyl Citrate (PDF - 19KB)DraftTransmucosal/OralTroche; Lozenge207472/2010
Fentanyl Citrate (PDF - 18KB)RevisedDraftOralTablet, Buccal219476/2013
Ferumoxytol (PDF -33KB)Draft IntravenousInjection2218012/2012

Fesoterodine Fumarate (PDF - 47KB)

DraftOralTablet, Extended Release2203011/2010
Fexofenadine HCl (PDF - 16KB)DraftOralSuspension2196312/2008
Fexofenadine HCl (PDF - 20KB)DraftOralTablet, Orally Disintegrating219098/2008
Fexofenadine HCl (PDF - 16KB)
Revised
DraftOralCapsule206259/2008
Fexofenadine HCl (PDF - 16KB)
Revised
DraftOralTablet0208729/2008
Fexofenadine HCl; Pseudoephedrine HCl (PDF - 18KB)DraftOralTablet, Extended Release

20786

21704

10/2009
Finasteride (PDF - 35KB)DraftOralTablet

20180

20788

1/2011
Fingolimod (PDF - 36KB)DraftOralCapsule225278/2011
Flavoxate HCl (PDF - 31KB)DraftOralTablet167695/2007
Flecainide Acetate (PDF - 17KB)DraftOralTablet0762782/2010
Fluconazole (PDF - 45KB)FinalOralTablet199495/2008
Flucytosine (PDF - 33KB)DraftOralCapsule170017/2010
Fludarabine Phosphate (PDF - 33KB)DraftOralTablet22273 3/2012
Fludrocortisone Acetate (PDF - 28KB)FinalOralTablet4043110/2011
Fluorouracil (PDF - 176KB)DraftTopicalCream169883/2011
Fluorouracil (PDF - 33KB)RevisedDraftTopicalSolution, 5%168316/2011
Fluorouracil (PDF - 33KB)RevisedDraftTopicalSolution, 2%168316/2011
Fluorouracil (PDF - 168KB) RevisedDraftTopicalCream209857/2014
Fluorouracil (PDF - 41KB)DraftTopicalCream168316/2010
Fluoxetine HCl (PDF - 33KB)DraftOralTablet218602/2011
Fluoxetine HCl (PDF - 33KB)DraftOralTablet757552/2011
Fluoxetine HCl (PDF - 78KB)DraftOralCapsule, Delayed Release212358/2010

 Fluoxetine HCl (PDF - 22KB)

Draft OralCapsule189366/2013
Fluoxetine HCl;Olanzapine(PDF - 16KB) RevisedDraftOralCapsule215207/2009
Flutamide (PDF - 23KB)DraftOralCapsule0757804/2013
Fluticasone Propionate (PDF - 35KB)DraftTopicalCream199582/2011

Fluticasone Propionate; Salmeterol Xinafoate (PDF - 114KB)

Draft InhalationPowder210779/2013
Fluvastatin Sodium (PDF - 18KB)DraftOralCapsule202611/2008
Fluvastatin Sodium (PDF - 19KB)DraftOralTablet, Extended Release211921/2008
Fluvoxamine Maleate (PDF - 36KB)DraftOralCapsule, Extended Release220332/2011
Fosamprenavir Calcium (PDF - 18KB)DraftOralSuspension2211611/2007
Fosamprenavir Calcium (PDF - 45KB)FinalOralTablet215485/2008
Fosinopril Sodium (PDF - 58KB)FinalOralTablet199155/2008
Fosinopril Sodium; Hydrochlorothiazide (PDF - 16KB)
Revised
DraftOralTablet202869/2008
Frovatriptan Succinate (PDF - 16KB)DraftOralTablet2100610/2008
Fulvestrant (PDF - 33KB)DraftInjection, IntramuscularSolution21344 3/2012
Furosemide (PDF - 34KB)DraftOralTablet162739/2010