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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 '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) Revised Draft Injection Injectable 21008 2/2014
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)Revised Draft Oral Tablet, Extended Release 20897 11/2013
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