Drugs

Product-Specific Recommendations for Generic Drug Development: 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

 Palbociclib  (PDF - 34KB)

Draft Oral Capsule 207103 4/2016
Paliperidone (PDF - 19KB) Revised Draft Oral Tablet, Extended Release 21999 3/2015
Paliperidone Palmitate (PDF - 35KB) Revised Draft Injection, Intramuscular Suspension, Extended Release 22264 7/2016
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) Revised Draft Oral Tablet, Extended Release 20936 6/2016
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 Draft 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
Phenytoin sodium (PDF - 23KB) Revised Draft Oral Capsule, Extended Release 040298 12/2014
Phenytoin sodium (PDF - KB) Revised Draft Oral Capsule, Extended Release 084349 12/2014
Phytonadione (PDF - 27KB)Revised Draft Oral Tablet 10104 1/2016
Phytonadione (PDF - 34KB) Revised Draft 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

 Pirfenidone  (PDF - 23KB) 

Draft Oral Capsule 022535 9/2015
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

 Pomalidomide (PDF - 24KB) Revised

Draft Oral Capsule 204026 6/2016

 Ponatinib HCl (PDF - 42KB)

Draft Oral Tablet 203469 9/2015
Posaconazole (PDF - 38KB) Draft Oral Suspension 22003 11/2007
Posaconazole (PDF - 25KB) Draft Oral Tablet, Delayed Release 205053 12/2014

 

Potassium chloride (PDF - 37KB) 
Draft Oral Tablet, Extended Release 018279 3/2015
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) Revised Draft Oral Tablet 22307 6/2015
Pravastatin Sodium (PDF - 45KB) Final Oral Tablet 19898 5/2008

 Praziquantel (PDF - 42KB) 

Draft Oral Tablet 18714 3/2015
Prednisolone (PDF - 15KB)Revised Draft Oral Tablet 80354 11/2010

 Prednisone (PDF - 38KB)

Draft Oral Tablet

084283

084122

087800

087801

807342

080352

1/2016
Prednisolone Acetate (PDF - 69KB) Revised Draft Ophthalmic Suspension/Drops 17011 6/2016
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

 Primaquine phosphate (PDF - 25KB)

Draft Oral Tablet 008316 6/2015
Procarbazine HCl (PDF -27KB) Draft Oral Capsule 16785 3/2012

 the word new in a red boxProgesterone (PDF - 106KB)

Draft Vaginal Gel 020701 10/2015
 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

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

 Pyrimethamine  (PDF - 22KB) 

Draft Oral Tablet 008578 3/2015

 

Page Last Updated: 08/25/2016
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