Drugs

Product-Specific Recommendations for Generic Drug Development: 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Octreotide Acetate (PDF - 34KB) RevisedDraftInjectionInjectable210082/2014
Ofloxacin (PDF - 30KB)DraftOphthalmicDrops, Solution199216/2011
Olanzapine (PDF - 21KB)DraftOralTablet205928/2008
Olanzapine (PDF - 47KB)FinalOralTablet, Orally Disintegrating210865/2008
Olmesartan Medoxomil (PDF - 49KB)FinalOralTablet212865/2008
Olopatadine HCl (PDF - 14KB)DraftOphthalmicSolution

21545

20688

9/2008
Olsalazine Sodium (PDF - 50KB)FinalOralCapsule197155/2008
Omega-3-Acid Ethyl Esters (PDF - 100KB)Draft OralCapsule216549/2012
Omeprazole (PDF - 17KB)Draft OralTablet, Delayed Release0220329/2012
Omeprazole (PDF - 43KB)RevisedFinalOralCapsule, Delayed Release1981011/2008
Omeprazole Magnesium (PDF - 46KB)FinalOralTablet, Delayed Release212295/2008
Omeprazole; Sodium Bicarbonate (PDF - 15KB)DraftOralCapsule218497/2008
Omeprazole; Sodium Bicarbonate (PDF - 16KB)
Revised
DraftOralSuspension216367/2009
Omeprazole, Sodium Bicarbonate; Magnesium Hydroxide (PDF - 17KB)DraftOralTablet, Chewable218502/2008
Ondasetron (PDF - 24KB)DraftOralFilm225243/2012
Ondansetron (PDF - 50KB)FinalOralTablet, Orally Disintegrating207815/2008
Ondansetron HCl (PDF - 48KB)FinalOralTablet201035/2008
Orlistat (PDF - 79KB) RevisedDraftOralCapsule

21887

20766

8/2010
Orphenadrine Citrate (PDF - 17KB)DraftOralTablet, Extended Release403274/2010
Oseltamivir Phosphate (PDF - 16KB)DraftOralCapsule2108712/2009
Oseltamivir Phosphate (PDF - 16KB) RevisedDraftOralSuspension212463/2015

Ospemifene (PDF - 22KB) 

DraftOralTablet2035057/2014

Oxcarbazepine (PDF- 27KB)

DraftOralTablet, Extended Release2028107/2014
Oxcarbazepine (PDF - 53KB)FinalOralSuspension212855/2008
Oxcarbazepine (PDF - 53KB)FinalOralTablet210145/2008
Oxiconazole Nitrate (PDF - 61KB)DraftTopicalCream198283/2012
Oxiconazole Nitrate (PDF - 65KB)DraftTopicalLotion202093/2012
Oxybutynin (PDF - 125KB)DraftTransdermalFilm, Extended Release2135112/2009

 Oxybutynin chloride (PDF - 42KB)

DraftOralTablet0750793/2015
Oxybutynin Chloride (PDF - 32KB)RevisedDraftOralTablet, Extended Release2089711/2013
Oxycodone (PDF - 16KB)DraftOralTablet2101112/2009
Oxycodone HCl (PDF - 41KB)DraftOralTablet, Extended Release2227212/2010
Oxymetholone (PDF - 33KB)DraftOralTablet168482/2011
Oxymorphone HCl(PDF - 17KB)DraftOralTablet216111/2008
Oxymorphone HCl (PDF - 21KB)
Revised
DraftOralTablet, Extended Release216102/2010

 

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