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Individual Product Bioequivalence Recommendations: Active Ingredients starting with 'P'

 

Dissolutions Methods Database

 

Individual Product Bioequivalence Recommendations 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
Paliperidone Draft Oral Tablet, Extended Release 21999 11/2007
Pantoprazole Sodium Final Oral Tablet, Delayed Release 20987 5/2008
Paricalcitol Draft Oral Capsule 21606 11/2007
Paroxetine HCl Draft Oral Tablet 20031 8/2008
Penicillamine Draft Oral Capsule 19853 8/2008
Perindopril Erbumine Final Oral Tablet 20184 5/2008
Phendimetrazine Tartrate Draft Oral Capsule, Extended Release 18074 8/2009
Phendimetrazine Tartrate Draft Oral Tablet 85272 8/2009
Phenoxybenzamine Draft Oral Capsule 08708 7/2008
Phentermine HCl Draft Oral Capsule

88023

87190

5/2009
Phentermine HCl Draft Oral Tablet

85128

88605

5/2009
Phenytoin Sodium Final Oral Capsule, Extended 84349 5/2008
Phenytoin Sodium Final Oral Capsule, Extended 40298 5/2008
Phenytoin Draft Oral Tablet, Chewable 84427 1/2008
Phenytoin Final Oral Suspension 08762 5/2008
Phytonadione Draft Injectable Injection

87954

87955

5/2009
Pilocarpine HCl Final Oral Tablet 20237 5/2008
Pimozide Draft Oral Tablet 17473 2/2008
Posaconazole Draft Oral Suspension 22003 11/2007
Pramipexole Dihydrochloride Draft Oral Tablet 20667 12/2008
Pravastatin Sodium Final Oral Tablet 19898 5/2008
Prednisolone Draft Oral Tablet 80354 3/2009
Prednisolone Sodium Phosphate Draft Oral Tablet, Orally Disintegrating 21959 8/2008
Pregabalin Draft Oral Capsule 21446 5/2009
Propafenone HCl Draft Oral Tablet 19151 5/2009
Pyridostigmine Bromide Draft Oral Tablet 09829 8/2009
    
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