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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 '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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
Sapropterin Dihydrochloride (PDF - 18KB)Revised Draft Oral Tablet 22181 9/2012
Saquinavir Mesylate (PDF - 37KB) Draft Oral Capsule 20628 11/2007
Saquinavir Mesylate (PDF - 52KB) Draft Oral Tablet 21785 11/2007

 

Saxagliptin HCl (PDF - 18KB)

Draft Oral Tablet 22350 9/2012
Scopolamine (PDF - 270KB)
Final Transdermal Film, Extended Release 17874 10/2011
Selegiline (PDF - 288KB) Final Transdermal Film, Extended Release 21336 10/2011
Selegiline HCl (PDF - 18KB) Draft Oral Tablet, Orally Disintegrating 21479 9/2008
Sevelamer Carbonate (PDF - 45KB) Draft Oral Suspension 22318 6/2011
Sevelamer Carbonate (PDF - 43KB)
Revised
Draft Oral Tablet 22127 6/2011
Sevelamer HCl (PDF - 44KB)
Revised
Draft Oral Tablet 21179 8/2011
Sertraline HCl (PDF - 46KB) Final Oral Tablet 19839 5/2008
Sibutramine HCl Final Oral Capsule 20632 5/2008
Sildenafil Citrate (PDF - 18KB)
Revised

Draft
Oral Tablet

20895

21845

12/2008
Silodosin (PDF - 24KB) Draft Oral Capsule 22206 4/2013
Simvastatin (PDF - 46KB) Final Oral Tablet 19766 5/2008
Simvastatin (PDF - 23KB) Draft Oral Tablet, Orally Disintegrating 21961 8/2008
Sirolimus (PDF - 16KB)
Revised
Draft Oral Tablet 21110 10/2010
Sitagliptin Phosphate (PDF - 35KB) Draft Oral Tablet 21995 7/2010
 Sodium Ferric Gluconate Complex (PDF - 32KB) Draft Injectable Injection 20955 6/2013
Sodium Iodide, I-123 (PDF - 15KB) Draft Oral Capsule 18671 7/2008
Sodium Phenylbutyrate (PDF - 16KB) Draft Oral Powder 20573 5/2009
Sodium Phenylbutyrate (PDF - 16KB) Draft Oral Tablet 20572 5/2009

 

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

Draft Oral Tablet

021892

12/2012
Solifenacin Succinate (PDF - 13KB) Draft Oral Tablet 21518 2/2008
Sorafenib Tosylate (PDF - 29KB)Revised Final Oral Tablet 21923 6/2012
Sotalol HCl (PDF - 38KB) Draft Oral Tablet 19865 12/2010

Sotalol HCl (PDF - 39KB)

Draft Oral Tablet 21151 12/2010
Spironolactone (PDF - 16KB) Draft Oral Tablet 12151 12/2009
Stavudine (PDF - 48KB) Final Oral Capsule 20412 5/2008

Sucralfate (PDF - 81KB)

Draft Oral Suspension 19183 7/2014

Sucralfate  (PDF - 81KB)

Draft Oral Tablet 18333 7/2014
Sulfacetamide Sodium (PDF - 215KB) Draft Topical Lotion (or "Suspension USP") 19931 5/2010
Sulfadiazine (PDF - 15KB) Draft Oral Tablet 40091 7/2008
Sulfamethoxazole; Trimethoprim (PDF - 42KB) Final Oral Suspension 77612 5/2008
Sulfamethoxazole; Trimethoprim (PDF - 20KB) Draft Oral Tablet 17377 8/2008
Sulfasalazine (PDF - 28KB) Draft Oral Tablet, Delayed Release 07073 2/2010
Sulfasalazine (PDF - 27KB) Draft Oral Tablet 07073 2/2010
Sumatriptan (PDF - (19KB)Revised Draft Nasal Spray 20626 9/2012
Sumatriptan Succinate (PDF - 45KB) Final Oral Tablet 20132 5/2008
Sunitinib Malate (PDF - 16KB) Draft Oral Capsule 21938 4/2010