• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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

 

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
Rabeprazole Sodium (PDF - 27KB)DraftOralCapsule, Delayed Release2047364/2014

Rabeprazole Sodium (PDF - 35KB)

DraftOralTablet, Delayed Release2097312/2010
Raloxifene HCl (PDF - 46KB)FinalOralTablet208155/2008
Raltegravir Potassium (PDF - 28KB)FinalOralTablet2214510/2011
Ramelteon (PDF - 34KB)FinalOralTablet2178210/2011
Ramipril (PDF - 22KB)DraftOralTablet220218/2008
Ramipril (PDF - 48KB)FinalOralCapsule199015/2008
Ranitidine HCl (PDF - 16KB)DraftOralTablet, Effervescent202512/2010
Raniditine HCl (PDF - 16KB)DraftOralTablet

20520

21698

11/2009
Raniditine HCl (PDF - 17KB)DraftOralTablet1870311/2009
Ranolazine (PDF - 44KB)DraftOralTablet, Extended Release215268/2010
Rasagiline Mesylate (PDF - 16KB)DraftOralTablet2164111/2009
Repaglinide (PDF - 22KB)DraftOralTablet207418/2008
Ribavirin (PDF - 44KB)FinalOralCapsule209035/2008
Ribavirin (PDF - 45KB)FinalOralTablet774565/2008
Rifabutin (PDF - 26KB)DraftOralCapsule506892/2010
Rifaximin (PDF - 37KB) DraftOralTablet225542/2012
Rifampin (PDF - 46KB)FinalOralCapsule

50420

62303

5/2008
Rifaximin (PDF - 217KB) DraftOralTablet2136111/2011

 

Rilpivirine HCl (PDF - 17KB) 

DraftOralTablet2020229/2012
Riluzole (PDF - 45KB)FinalOralTablet205995/2008
Rimexolone (PDF - 21KB)DraftOphthalmicDrops, Suspension0204744/2013
Risedronate Sodium (PDF - 40KB) RevisedDraftOralTablet, Delayed Release2256012/2012
Risedronate Sodium; Calcium Carbonate (PDF - 45KB)FinalOralTablet218235/2008
Risedronate Sodium (PDF - 16KB)
Revised
DraftOralTablet2083512/2008
Risperidone (PDF - 35KB)DraftOralTablet, Orally disintegrating214447/2010
Risperidone (PDF - 15KB) RevisedDraftIntramuscularInjection213468/2013
Risperidone (PDF - 33KB)DraftOralTablet202725/2007
Ritonavir (PDF - 37KB)DraftOralTablet224176/2011
Ritonavir (PDF - 43KB)FinalOralCapsule209455/2008
Rivastigmine (PDF - 288KB) RevisedDraftTransdermalFilm, Extended Release2208311/2013
Rivastigmine Tartrate (PDF - 19KB)
Revised
DraftOralCapsule208232/2010
Rizatriptan Benzoate (PDF - 21KB)DraftOralTablet, Orally Disintegrating208654/2013
Rizatriptan Benzoate (PDF - 48KB)FinalOralTablet208645/2008

 

Roflumilast (PDF - 17KB)

DraftOralTablet225229/2012
Ropinirole HCl (PDF - 19KB)
Revised
DraftOralTablet, Extended Release220082/2010
Rosiglitazone Maleate (PDF - 53KB)FinalOralTablet210715/2008
Rosuvastatin calcium (PDF - 48KB)FinalOralTablet213665/2008
 Rotigotine (PDF - 366KB) Draft TransdermalFilm, Extended Release218296/2012
 Rufinamide (PDF - 39KB) Draft OralSuspension2013676/2012
Rufinamide (PDF - 33KB)DraftOralTablet219118/2011