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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'P'
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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) | Draft | Injection, Intramuscular | Suspension | 22264 | 8/2011 |
| 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 |
| 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) | Draft | Oral | Capsule | 20193 | 9/2012 |
| Perindopril Erbumine (PDF - 50KB) | Final | Oral | Tablet | 20184 | 5/2008 |
| Perphenazine (PDF - 26KB) | Draft | Oral | Tablet | 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 - 32KB) | Final | Oral | Capsule | 10/2011 | |
| Phentermine HCl (PDF - 25KB) | Final | Oral | Tablet | 10/2011 | |
| Phenytoin Sodium (PDF - 22KB) | Final | Oral | Capsule, Extended | 84349 | 5/2008 |
| Phenytoin Sodium (PDF - 45KB) | Final | Oral | Capsule, Extended | 40298 | 5/2008 |
| 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 | 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 |
| 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 - 29KB) | Draft | Oral | Suspension | 22067 | 2/2010 |
| Prednisolone Sodium Phosphate (PDF - 21KB) | Draft | Oral | Tablet, Orally Disintegrating | 21959 | 8/2008 |
| 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 - 17KB) | Draft | Oral | Tablet | 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 -37KB)Revised | Draft | Oral | Tablet | 16418 | 9/2012 |
| Propylthiouracil (PDF - (19KB) | Draft | Oral | Tablet | 06188 | 3/2012 |
| 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 |
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