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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 'S'

 

 

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
Sapropterin Dihydrochloride (PDF - 18KB)RevisedDraftOralTablet221819/2012
Saquinavir Mesylate (PDF - 37KB)DraftOralCapsule2062811/2007
Saquinavir Mesylate (PDF - 52KB)DraftOralTablet2178511/2007

 

Saxagliptin HCl (PDF - 18KB)

DraftOralTablet223509/2012
Scopolamine (PDF - 270KB)
FinalTransdermalFilm, Extended Release1787410/2011
Selegiline (PDF - 288KB)FinalTransdermalFilm, Extended Release2133610/2011
Selegiline HCl (PDF - 18KB)DraftOralTablet, Orally Disintegrating214799/2008
Sevelamer Carbonate (PDF - 45KB)DraftOralSuspension223186/2011
Sevelamer Carbonate (PDF - 43KB)
Revised
DraftOralTablet221276/2011
Sevelamer HCl (PDF - 44KB)
Revised
DraftOralTablet211798/2011
Sertraline HCl (PDF - 46KB)FinalOralTablet198395/2008
Sibutramine HClFinalOralCapsule206325/2008
Sildenafil Citrate (PDF - 18KB)
Revised

Draft
OralTablet

20895

21845

12/2008
Silodosin (PDF - 24KB)DraftOralCapsule222064/2013
Simvastatin (PDF - 46KB)FinalOralTablet197665/2008
Simvastatin (PDF - 23KB)DraftOralTablet, Orally Disintegrating219618/2008
Sirolimus (PDF - 16KB)
Revised
DraftOralTablet2111010/2010
Sitagliptin Phosphate (PDF - 35KB)DraftOralTablet219957/2010
 Sodium Ferric Gluconate Complex (PDF - 32KB)DraftInjectableInjection209556/2013
Sodium Iodide, I-123 (PDF - 15KB)DraftOralCapsule186717/2008
Sodium Phenylbutyrate (PDF - 16KB)DraftOralPowder205735/2009
Sodium Phenylbutyrate (PDF - 16KB)DraftOralTablet205725/2009

 

Sodium phosphate dibasic anhydrous & sodium phosphate monobasic monohydrate (PDF - 30KB) 

DraftOralTablet

021892

12/2012
Solifenacin Succinate (PDF - 13KB)DraftOralTablet215182/2008
Sorafenib Tosylate (PDF - 29KB)RevisedFinalOralTablet219236/2012
Sotalol HCl (PDF - 38KB)DraftOralTablet1986512/2010

Sotalol HCl (PDF - 39KB)

DraftOralTablet2115112/2010
Spironolactone (PDF - 16KB)DraftOralTablet1215112/2009
Stavudine (PDF - 48KB)FinalOralCapsule204125/2008
Sulfacetamide Sodium (PDF - 215KB)DraftTopicalLotion (or "Suspension USP")199315/2010
Sulfadiazine (PDF - 15KB)DraftOralTablet400917/2008
Sulfamethoxazole; Trimethoprim (PDF - 42KB)FinalOralSuspension776125/2008
Sulfamethoxazole; Trimethoprim (PDF - 20KB)DraftOralTablet173778/2008
Sulfasalazine (PDF - 28KB)DraftOralTablet, Delayed Release070732/2010
Sulfasalazine (PDF - 27KB)DraftOralTablet070732/2010
Sumatriptan (PDF - (19KB)RevisedDraftNasalSpray206269/2012
Sumatriptan Succinate (PDF - 45KB)FinalOralTablet201325/2008
Sunitinib Malate (PDF - 16KB)DraftOralCapsule219384/2010