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U.S. Department of Health and Human Services

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'P'

 

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
 Paclitaxel (PDF - 68KB)Draft InjectionSuspension0216609/2012
Paliperidone (PDF - 19KB)RevisedDraftOralTablet, Extended Release219993/2012
Paliperidone Palmitate (PDF - 35KB) RevisedDraftInjection, IntramuscularSuspension2226412/2013
Palonosetron HCl (PDF - 36KB)DraftOralCapsule2223312/2010
Pantoprazole Sodium (PDF - 20KB)DraftOralGranules, Delayed Release Suspension2202012/2009
Pantoprazole Sodium (PDF - 42KB)FinalOralTablet, Delayed Release209875/2008
Paricalcitol (PDF - 39KB)DraftOralCapsule2160611/2007
Paroxetine (PDF - 18KB)DraftOralTablet, Extended Release2093612/2009
Paroxetine HCl (PDF - 21KB)DraftOralTablet200318/2008
 Pazopanib HCl (PDF - 30KB)Draft OralTablet0224659/2012
Penbutolol Sulfate (PDF - 33KB) DraftOralTablet189769/2010
Penicillamine (PDF - 20KB)DraftOralCapsule198538/2008
Penicillin V Potassium (PDF - 38KB)DraftOralTablet640716/2011
 Pentosan Polysulfate Sodium (PDF - 90KB)Draft OralCapsule201939/2012
Perindopril Erbumine (PDF - 50KB)FinalOralTablet201845/2008
Perphenazine (PDF - 26KB)DraftOralTablet

89686 

89685

89684 

89683 

2/2010
Phendimetrazine Tartrate (PDF - 34KB)FinalOralCapsule, Extended Release1807410/2011
Phendimetrazine Tartrate (PDF - 25KB)FinalOralTablet8527210/2011
Phenelzine Sulfate (PDF - 22KB)DraftOralTablet119094/2010
Phenoxybenzamine (PDF - 15KB)RevisedDraftOralCapsule0870812/2012

Phentermine HCl (PDF - 21KB)

Draft OralTablet, Disintegrating20208811/2013
Phentermine HCl (PDF - 32KB)FinalOralCapsule

88023

87190

10/2011
Phentermine HCl (PDF - 25KB)FinalOralTablet

85128

88605

10/2011
Phentermine HCl; Topiramate (PDF - 23KB) RevisedFinalOralCapsules, Extended Release225806/2013
Phenytoin Sodium (PDF - 22KB)FinalOralCapsule, Extended843495/2008
Phenytoin Sodium (PDF - 45KB)FinalOralCapsule, Extended402985/2008
Phenytoin (PDF - 18KB)DraftOralTablet, Chewable844271/2008
Phenytoin (PDF - 20KB)FinalOralSuspension087625/2008
Phytonadione (PDF - 27KB)RevisedDraftOralTablet101049/2012
Phytonadione (PDF - 34KB) RevisedFinalInjectableInjection

87954

87955

9/2012
Pilocarpine HCl (PDF - 47KB)FinalOralTablet202375/2008
Pimecrolimus (PDF - 72KB)DraftTopicalCream213023/2012
Pimozide (PDF - 18KB)DraftOralTablet174732/2008
Pioglitazone HCl (PDF - 17KB)DraftOralTablet2107312/2009
Piroxicam (PDF - 22KB)Draft OralCapsule1814712/2012
Pitavastatin (PDF - 37KB)DraftOralTablet223636/2011
 Podofilox (PDF - 172KB) Draft TopicalGel205296/2012
Podofilox (PDF - 34KB)DraftTopicalSolution197958/2011
Posaconazole (PDF - 38KB)DraftOralSuspension2200311/2007
Potassium Chloride (PDF - 34KB) DraftOralTablet, Extended Release1912310/2011
 Potassium Chloride (PDF - 34KB) DraftOralTablet, Extended Release747269/2011
Potassium Chloride (PDF - 103KB)DraftOralCapsules, Extended Release774198/2011
Potassium Citrate (PDF - 37KB)DraftOralTablet, Extended Release190718/2010
Pramipexole Dihydrochloride (PDF - 18KB)DraftOralTablet2066712/2008
Pramipexole Dihydrochloride (PDF - 41KB)DraftOralTablet, Extended Release224217/2010
Prasugrel HCl (PDF - 37 KB)DraftOralTablet223073/2011
Pravastatin Sodium (PDF - 45KB)FinalOralTablet198985/2008
Prednisolone (PDF - 15KB)RevisedDraftOralTablet8035411/2010
Prednisolone Acetate (PDF - 29KB)DraftOralSuspension220672/2010
Prednisolone Sodium Phosphate (PDF - 21KB)DraftOralTablet, Orally Disintegrating219598/2008

Prednisone (PDF - 37KB)

DraftOralTablet, Delayed Release20202011/2013
Pregabalin (PDF - 33KB)FinalOralCapsule2144610/2011
Procarbazine HCl (PDF -27KB)DraftOralCapsule167853/2012
 Progesterone (PDF - 23KB)DraftVaginalInsert220579/2012
Progesterone (PDF - 148KB) Revised 
New Version Posted 12/12/12 with corrections in formatting for legibility
DraftOralCapsule197812/2011
Promethazine HCl (PDF - 17KB)DraftOralTablet

84176

84234

2/2010
Propafenone HCl (PDF - 28KB)DraftOralCapsule, Extended Release2141612/2009
Propafenone HCl (PDF - 35KB)FinalOralTablet1915110/2011
Propranolol HCl (PDF -37KB)RevisedDraftOralTablet719769/2012
Propylthiouracil (PDF - (19KB)DraftOralTablet061883/2012

Protriptyline HCl (PDF - 38KB)

DraftOralTablet7364512/2010
Pseudoephedrine HCl (PDF - 35KB)DraftOralTablet, Extended Release200218/2010
Pyridostigmine Bromide (PDF - 34KB)DraftOralTablet, Extended Release116658/2011
Pyridostigmine Bromide (PDF - 28KB)FinalOralTablet0982910/2011