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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 '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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended

Rabeprazole Na (PDF - 35KB)

Draft Oral Tablet, Delayed Release 20973 12/2010
Raloxifene HCl (PDF - 46KB) Final Oral Tablet 20815 5/2008
Raltegravir Potassium (PDF - 28KB) Final Oral Tablet 22145 10/2011
Ramelteon (PDF - 34KB) Final Oral Tablet 21782 10/2011
Ramipril (PDF - 22KB) Draft Oral Tablet 22021 8/2008
Ramipril (PDF - 48KB) Final Oral Capsule 19901 5/2008
Ranitidine HCl (PDF - 16KB) Draft Oral Tablet, Effervescent 20251 2/2010
Raniditine HCl (PDF - 16KB) Draft Oral Tablet

20520

21698

11/2009
Raniditine HCl (PDF - 17KB) Draft Oral Tablet 18703 11/2009
Ranolazine (PDF - 44KB) Draft Oral Tablet, Extended Release 21526 8/2010
Rasagiline Mesylate (PDF - 16KB) Draft Oral Tablet 21641 11/2009
Repaglinide (PDF - 22KB) Draft Oral Tablet 20741 8/2008
Ribavirin (PDF - 44KB) Final Oral Capsule 20903 5/2008
Ribavirin (PDF - 45KB) Final Oral Tablet 77456 5/2008
Rifabutin (PDF - 26KB) Draft Oral Capsule 50689 2/2010
Rifaximin (PDF - 37KB)  Draft Oral Tablet 22554 2/2012
Rifampin (PDF - 46KB) Final Oral Capsule

50420

62303

5/2008
Rifaximin (PDF - 217KB)  Draft Oral Tablet 21361 11/2011

 

Rilpivirine HCl (PDF - 17KB) 

Draft Oral Tablet 202022 9/2012
Riluzole (PDF - 45KB) Final Oral Tablet 20599 5/2008
Rimexolone (PDF - 21KB) Draft Ophthalmic Drops, Suspension 020474 4/2013
Risedronate Sodium (PDF - 40KB) Revised Draft Oral Tablet, Delayed Release 22560 12/2012
Risedronate Sodium; Calcium Carbonate (PDF - 45KB) Final Oral Tablet 21823 5/2008
Risedronate Sodium (PDF - 16KB)
Revised
Draft Oral Tablet 20835 12/2008
Risperidone (PDF - 35KB) Draft Oral Tablet, Orally disintegrating 21444 7/2010
Risperidone (PDF - 15KB) Revised Draft Intramuscular Injection 21346 8/2013
Risperidone (PDF - 33KB) Draft Oral Tablet 20272 5/2007
Ritonavir (PDF - 37KB) Draft Oral Tablet 22417 6/2011
Ritonavir (PDF - 43KB) Final Oral Capsule 20945 5/2008
Rivastigmine (PDF - 288KB) Revised Draft Transdermal Film, Extended Release 22083 11/2013
Rivastigmine Tartrate (PDF - 19KB)
Revised
Draft Oral Capsule 20823 2/2010
Rizatriptan Benzoate (PDF - 21KB) Draft Oral Tablet, Orally Disintegrating 20865 4/2013
Rizatriptan Benzoate (PDF - 48KB) Final Oral Tablet 20864 5/2008

 

Roflumilast (PDF - 17KB)

Draft Oral Tablet 22522 9/2012
Ropinirole HCl (PDF - 19KB)
Revised
Draft Oral Tablet, Extended Release 22008 2/2010
Rosiglitazone Maleate (PDF - 53KB) Final Oral Tablet 21071 5/2008
Rosuvastatin calcium (PDF - 48KB) Final Oral Tablet 21366 5/2008
 Rotigotine (PDF - 366KB)  Draft  Transdermal Film, Extended Release 21829 6/2012
 Rufinamide (PDF - 39KB)  Draft  Oral Suspension 201367 6/2012
Rufinamide (PDF - 33KB) Draft Oral Tablet 21911 8/2011