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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'S'
- Drug-Related Guidances Main Page
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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 |
|
|
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 | 12/2008 | |
| 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 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 | 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 |
| Draft | Oral | Tablet | 21151 | 12/2010 | |
| Spironolactone (PDF - 16KB) | Draft | Oral | Tablet | 12151 | 12/2009 |
| Stavudine (PDF - 48KB) | Final | Oral | Capsule | 20412 | 5/2008 |
| 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 |
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