Drugs
Bioequivalence Recommendations for Specific Products: Active Ingredients Starting with 'O'
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 |
|---|
| Octreotide Acetate (PDF - 34KB) | Draft | Injection | Injectable | 21008 | 1/2011 |
| Ofloxacin (PDF - 30KB) | Draft | Ophthalmic | Drops, Solution | 19921 | 6/2011 |
| Olanzapine (PDF - 21KB) | Draft | Oral | Tablet | 20592 | 8/2008 |
| Olanzapine (PDF - 47KB) | Final | Oral | Tablet, Orally Disintegrating | 21086 | 5/2008 |
| Olmesartan Medoxomil (PDF - 49KB) | Final | Oral | Tablet | 21286 | 5/2008 |
| Olopatadine HCl (PDF - 14KB) | Draft | Ophthalmic | Solution | 21545 20688 | 9/2008 |
| Olsalazine Sodium (PDF - 50KB) | Final | Oral | Capsule | 19715 | 5/2008 |
| Omega-3-Acid Ethyl Esters (PDF - 100KB) | Draft | Oral | Capsule | 21654 | 9/2012 |
| Omeprazole (PDF - 17KB) | Draft | Oral | Tablet, Delayed Release | 022032 | 9/2012 |
| Omeprazole (PDF - 43KB)Revised | Final | Oral | Capsule, Delayed Release | 19810 | 11/2008 |
| Omeprazole Magnesium (PDF - 46KB) | Final | Oral | Tablet, Delayed Release | 21229 | 5/2008 |
| Omeprazole; Sodium Bicarbonate (PDF - 15KB) | Draft | Oral | Capsule | 21849 | 7/2008 |
Omeprazole; Sodium Bicarbonate (PDF - 16KB)
Revised | Draft | Oral | Suspension | 21636 | 7/2009 |
| Omeprazole, Sodium Bicarbonate; Magnesium Hydroxide (PDF - 17KB) | Draft | Oral | Tablet, Chewable | 21850 | 2/2008 |
| Ondasetron (PDF - 24KB) | Draft | Oral | Film | 22524 | 3/2012 |
| Ondansetron (PDF - 50KB) | Final | Oral | Tablet, Orally Disintegrating | 20781 | 5/2008 |
| Ondansetron HCl (PDF - 48KB) | Final | Oral | Tablet | 20103 | 5/2008 |
| Orlistat (PDF - 79KB) Revised | Draft | Oral | Capsule | 21887 20766 | 8/2010 |
| Orphenadrine Citrate (PDF - 17KB) | Draft | Oral | Tablet, Extended Release | 40327 | 4/2010 |
| Oseltamivir Phosphate (PDF - 16KB) | Draft | Oral | Capsule | 21087 | 12/2009 |
| Oseltamivir Phosphate (PDF - 16KB) | Draft | Oral | Suspension | 21246 | 12/2009 |
| Oxcarbazepine (PDF - 53KB) | Final | Oral | Suspension | 21285 | 5/2008 |
| Oxcarbazepine (PDF - 53KB) | Final | Oral | Tablet | 21014 | 5/2008 |
| Oxiconazole Nitrate (PDF - 61KB) | Draft | Topical | Cream | 19828 | 3/2012 |
| Oxiconazole Nitrate (PDF - 65KB) | Draft | Topical | Lotion | 20209 | 3/2012 |
| Oxybutynin (PDF - 125KB) | Draft | Transdermal | Film, Extended Release | 21351 | 12/2009 |
| Oxybutynin Chloride (PDF - 32KB) | Final | Oral | Tablet, Extended Release | 20897 | 10/2011 |
| Oxycodone (PDF - 16KB) | Draft | Oral | Tablet | 21011 | 12/2009 |
| Oxycodone HCl (PDF - 41KB) | Draft | Oral | Tablet, Extended Release | 22272 | 12/2010 |
| Oxymetholone (PDF - 33KB) | Draft | Oral | Tablet | 16848 | 2/2011 |
| Oxymorphone HCl(PDF - 17KB) | Draft | Oral | Tablet | 21611 | 1/2008 |
Oxymorphone HCl (PDF - 21KB)
Revised | Draft | Oral | Tablet, Extended Release | 21610 | 2/2010 |
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