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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 '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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
 Paclitaxel (PDF - 68KB) Draft  Injection Suspension 021660 9/2012
Paliperidone (PDF - 19KB)Revised Draft Oral Tablet, Extended Release 21999 3/2012
Paliperidone Palmitate (PDF - 35KB) Revised Draft Injection, Intramuscular Suspension 22264 12/2013
Palonosetron HCl (PDF - 36KB) Draft Oral Capsule 22233 12/2010
Pantoprazole Sodium (PDF - 20KB) Draft Oral Granules, Delayed Release Suspension 22020 12/2009
Pantoprazole Sodium (PDF - 42KB) Final Oral Tablet, Delayed Release 20987 5/2008
Paricalcitol (PDF - 39KB) Draft Oral Capsule 21606 11/2007
Paroxetine (PDF - 18KB) Draft Oral Tablet, Extended Release 20936 12/2009
Paroxetine HCl (PDF - 21KB) Draft Oral Tablet 20031 8/2008

Paroxetine Mesylate (PDF - 20KB)

Draft Oral Capsule 204516 7/2014
 Pazopanib HCl (PDF - 30KB) Draft  Oral Tablet 022465 9/2012
Penbutolol Sulfate (PDF - 33KB)  Draft Oral Tablet 18976 9/2010
Penicillamine (PDF - 20KB) Draft Oral Capsule 19853 8/2008
Penicillin V Potassium (PDF - 38KB) Draft Oral Tablet 64071 6/2011
 Pentosan Polysulfate Sodium (PDF - 90KB)Revised Draft  Oral Capsule 20193 7/2014
Perampanel (PDF - 21KB) Draft Oral Tablet 202834 4/2014
Perindopril Erbumine (PDF - 50KB) Final Oral Tablet 20184 5/2008
Perphenazine (PDF - 26KB) Draft Oral Tablet

89686 

89685

89684 

89683 

2/2010
Phendimetrazine Tartrate (PDF - 34KB) Final Oral Capsule, Extended Release 18074 10/2011
Phendimetrazine Tartrate (PDF - 25KB) Final Oral Tablet 85272 10/2011
Phenelzine Sulfate (PDF - 22KB) Draft Oral Tablet 11909 4/2010
Phenoxybenzamine (PDF - 15KB)Revised Draft Oral Capsule 08708 12/2012

Phentermine HCl (PDF - 21KB)

Draft  Oral Tablet, Disintegrating 202088 11/2013
Phentermine HCl (PDF - 32KB) Final Oral Capsule

88023

87190

10/2011
Phentermine HCl (PDF - 25KB) Final Oral Tablet

85128

88605

10/2011
Phentermine HCl; Topiramate (PDF - 23KB) Revised Final Oral Capsules, Extended Release 22580 6/2013
Phenytoin (PDF - 18KB) Draft Oral Tablet, Chewable 84427 1/2008
Phenytoin (PDF - 20KB) Final Oral Suspension 08762 5/2008
Phytonadione (PDF - 27KB)Revised Draft Oral Tablet 10104 9/2012
Phytonadione (PDF - 34KB) Revised Final Injectable Injection

87954

87955

9/2012
Pilocarpine HCl (PDF - 47KB) Final Oral Tablet 20237 5/2008
Pimecrolimus (PDF - 72KB) Draft Topical Cream 21302 3/2012
Pimozide (PDF - 18KB) Draft Oral Tablet 17473 2/2008
Pindolol (PDF - 23KB) Draft Oral Tablet 74019 4/2014
Pioglitazone HCl (PDF - 17KB) Draft Oral Tablet 21073 12/2009
Piroxicam (PDF - 22KB) Draft  Oral Capsule 18147 12/2012
Pitavastatin (PDF - 37KB) Draft Oral Tablet 22363 6/2011
 Podofilox (PDF - 172KB)  Draft  Topical Gel 20529 6/2012
Podofilox (PDF - 34KB) Draft Topical Solution 19795 8/2011
Posaconazole (PDF - 38KB) Draft Oral Suspension 22003 11/2007
Potassium Chloride (PDF - 34KB)  Draft Oral Tablet, Extended Release 19123 10/2011
 Potassium Chloride (PDF - 34KB)  Draft Oral Tablet, Extended Release 74726 9/2011
Potassium Chloride (PDF - 103KB) Draft Oral Capsules, Extended Release 77419 8/2011
Potassium Citrate (PDF - 37KB) Draft Oral Tablet, Extended Release 19071 8/2010
Pramipexole Dihydrochloride (PDF - 18KB) Draft Oral Tablet 20667 12/2008
Pramipexole Dihydrochloride (PDF - 41KB) Draft Oral Tablet, Extended Release 22421 7/2010
Prasugrel HCl (PDF - 37 KB) Draft Oral Tablet 22307 3/2011
Pravastatin Sodium (PDF - 45KB) Final Oral Tablet 19898 5/2008
Prednisolone (PDF - 15KB)Revised Draft Oral Tablet 80354 11/2010
Prednisolone Acetate (PDF - 69KB) Draft Ophthalmic Suspension/Drops 17011 4/2014
Prednisolone Acetate (PDF - 29KB) Draft Oral Suspension 22067 2/2010
Prednisolone Sodium Phosphate (PDF - 21KB) Draft Oral Tablet, Orally Disintegrating 21959 8/2008

Prednisone (PDF - 37KB)

Draft Oral Tablet, Delayed Release 202020 11/2013
Pregabalin (PDF - 33KB) Final Oral Capsule 21446 10/2011
Procarbazine HCl (PDF -27KB) Draft Oral Capsule 16785 3/2012
 Progesterone (PDF - 23KB) Draft Vaginal Insert 22057 9/2012
Progesterone (PDF - 148KB) Revised 
New Version Posted 12/12/12 with corrections in formatting for legibility
Draft Oral Capsule 19781 2/2011

Promethazine HCl  (PDF - 22KB) 

Draft Rectal Suppository 040428 7/2014

Promethazine HCl (PDF - 22KB)

Draft Rectal Suppository 087165 7/2014
Promethazine HCl (PDF - 17KB) Draft Oral Tablet

84176

84234

2/2010
Propafenone HCl (PDF - 28KB) Draft Oral Capsule, Extended Release 21416 12/2009
Propafenone HCl (PDF - 35KB) Final Oral Tablet 19151 10/2011

Propranolol HCl (PDF - 25KB)

Draft Oral Capsule, Extended Release 018553 7/2014
Propranolol HCl (PDF -37KB)Revised Draft Oral Tablet 71976 9/2012
Propylthiouracil (PDF - (19KB) Draft Oral Tablet 06188 3/2012

Protriptyline HCl (PDF - 38KB)

Draft Oral Tablet 73645 12/2010
Pseudoephedrine HCl (PDF - 35KB) Draft Oral Tablet, Extended Release 20021 8/2010
Pyridostigmine Bromide (PDF - 34KB) Draft Oral Tablet, Extended Release 11665 8/2011
Pyridostigmine Bromide (PDF - 28KB) Final Oral Tablet 09829 10/2011