Drugs

Product-Specific Recommendations for Generic Drug Development: 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

Sacubitril; Valsartan (PDF - 39KB)

DraftOralTablet2076204/2016
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) Revised
Draft, RevisionTransdermalFilm, Extended Release1787410/2016
Selegiline (PDF - 288KB) RevisedDraft, RevisionTransdermalFilm, Extended Release2133610/2016
Selegiline HCl (PDF - 18KB)DraftOralTablet, Orally Disintegrating214799/2008
Selegiline hydrochloride (PDF - 49KB)DraftOralCapsule02064712/2014

 Selexipag (PDF - 42KB)

DraftOralTablet2079476/2016
Sevelamer Carbonate (PDF - 45KB) DraftOralSuspension2231812/2014
Sevelamer Carbonate (PDF - 43KB)
DraftOralTablet221279/2015
Sevelamer HCl (PDF - 44KB)
DraftOralTablet2117912/2014
Sertraline HCl (PDF - 46KB)FinalOralTablet198395/2008
Sibutramine HClFinalOralCapsule206325/2008

 Sildenafil citrate (PDF - 42KB)

DraftOralSuspension2031096/2015
Sildenafil Citrate (PDF - 18KB)
Revised

Draft
OralTablet

20895

21845

12/2008
Silodosin (PDF - 24KB)DraftOralCapsule222064/2013

 Simeprevir sodium (PDF - 39KB) 

DraftOralCapsule2051236/2015
Simvastatin (PDF - 46KB)FinalOralTablet197665/2008
Simvastatin (PDF - 23KB)DraftOralTablet, Orally Disintegrating219618/2008
Sirolimus (PDF - 16KB)
Revised
DraftOralTablet211109/2015
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

 Sodium polystyrene sulfonate  (PDF - 16KB) 

DraftOral/RectalPowder0112873/2015

 Sofosbuvir (PDF - 23KB)

DraftOralTablet2046716/2015
Solifenacin Succinate (PDF - 13KB)DraftOralTablet215182/2008

 Sonidegib Phosphate (PDF - 56KB)

DraftOralCapsule2052664/2016
Sorafenib Tosylate (PDF - 29KB)DraftOralTablet219236/2012
Sotalol HCl (PDF - 38KB)DraftOralTablet1986512/2010

Sotalol HCl (PDF - 39KB)

DraftOralTablet2115112/2010

 Spinosad (PDF - 128KB)

DraftTopicalSuspension0224081/2016
Spironolactone (PDF - 16KB)DraftOralTablet1215112/2009
Stavudine (PDF - 48KB)FinalOralCapsule204125/2008

 

Sucroferric oxyhydroxide (PDF - 26KB)  
DraftOralTablet, Chewable2051093/2015
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

 Suvorexant  (PDF - 39KB)

DraftOralTablet2045699/2015

 

Page Last Updated: 11/01/2016
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