Drugs

Product-Specific Recommendations for Generic Drug Development: Active Ingredients Starting with 'N'

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
Nabilone (PDF - 15KB)
Revised
DraftOralCapsule186777/2009
Nabumetone (PDF - 43KB)FinalOralTablet751895/2008
Nadolol (PDF - 28KB)FinalOralTablet1806310/2011
Naftifine HCl (PDF -68KB)DraftTopicalCream195993/2012
Naftifine HCl (PDF - 57KB)DraftTopicalGel193563/2012

 Naftifine HCl (PDF - 132KB) 

DraftTopicalCream0195991/2016

 Naftifine HCl (PDF - 135KB)

DraftTopicalGel2042861/2016

 Naloxegol oxalate (PDF -39KB)

DraftOralTablet2047606/2015
Naltrexone (PDF - 17KB) RevisedDraftIntramuscularSuspension, Extended Release218979/2015
Naltrexone HCl (PDF -17KB)DraftOralTablet

18932

76264

12/2009
Naproxen (PDF - 26KB)DraftOralTablet, Delayed Release200672/2010
Naproxen (PDF - 16KB)DraftOralTablet175817/2008

 Naproxen sodium (PDF - 22KB)

DraftOralCapsule219206/2015
Naproxen Sodium (PDF - 17KB) DraftOralTablet, Extended Release203534/2010
Naproxen Sodium (PDF - 16KB)DraftOralTablet181647/2008
Naproxen Sodium (PDF - 16KB)DraftOralTablet202047/2008
Naproxen Sodium; Sumatriptan Succinate (PDF - 29KB)DraftOralTablet219268/2010
Naratriptan HCl (PDF - 16KB)DraftOralTablet207637/2008
Nateglinide (PDF - 53KB)FinalOralTablet212045/2008
Nebivolol (PDF -36KB) RevisedDraftOralTablet2174212/2014
Nelfinavir Mesylate (PDF - 52KB)DraftOralSuspension2077811/2007
Nelfinavir Mesylate (PDF - 50KB)FinalOralTablet

20779

21503
 

5/2008
Nepafenac (PDF - 73KB)DraftOphthalmicDrops, Suspension 0.1%2186212/2014
Nepafenac (PDF - 78KB)DraftOphthalmicDrops, Suspension 0.3%20349112/2014

 Netupitant; Palonosetron HCl (PDF - 52KB) 

DraftOralCapsule2057189/2015
Nevirapine (PDF - 24KB)RevisedDraftOralTablet, Extended Release2011527/2014
Nevirapine (PDF - 50KB)FinalOralSuspension209335/2008
Nevirapine (PDF - 51KB)DraftOralTablet2063611/2007
Niacin (PDF - 21KB)
Revised
DraftOralTablet, Extended Release2038112/2009
Niacin; Simvastatin (PDF - 42KB) RevisedDraftOralTablet, Extended Release2207811/2011
Nicardipine HCl (PDF - 18KB)DraftOralCapsule, Extended Release200057/2008

Nicotine (PDF - 153KB)

DraftTransdermalFilm, Extended Release20076

 

20165

11/2013

 Nicotine (PDF - 27KB)

DraftNasalSpray, Metered0203851/2016

Nicotine Polacrilex (PDF - 25KB)

DraftBuccalChewing Gum20066

18612

11/2013
Nicotine Polacrilex (PDF - 35KB)DraftOralLozenge223601/2011
Nifedipine (PDF - 19KB)Draft OralTablet, Extended Release201989/2012
Nifedipine (PDF - 38KB)DraftOralCapsule184826/2011
Nifedipine (PDF - 30KB)FinalOralTablet, Extended Release1968410/2011
Nilotinib HCl Monohydrate (PDF - 19KB)RevisedDraftOralCapsule220687/2014
Nilutamide (PDF - 25KB)
Revised
FinalOralTablet2016910/2011

 Nintedanib esylate (PDF - 40KB)

DraftOralCapsule2058329/2015
Nisoldipine (PDF - 38KB)
Revised
DraftOralTablet, Extended Release07905112/2014
Nisoldipine (PDF - 42KB)
Revised
DraftOralTablet, Extended Release0203563/2015
Nitazoxanide (PDF - 85KB)FinalOralTablet2149710/2011
Nitrofurantoin (PDF - 26KB)FinalOralSuspension0917510/2011
Nitrofurantoin; Nitrofurantoin, Macrocrystalline (PDF - 24KB)DraftOralCapsule200643/2012
Nitrofurantoin Macrocrystalline (PDF - 31KB)FinalOralCapsule1662010/2011

 Nitroglycerin  (PDF - 39KB)

DraftTransdermalOintment0873556/2015
Nitroglycerin (PDF - 19KB) RevisedDraftSublingualAerosol, Metered217802/2012
Nitroglycerin (PDF - 17KB)
Revised
DraftSublingualTablet211342/2011
Nitroglycerin (PDF - 19KB) RevisedDraftOral/SublingualSpray, Metered187052/2012
Nitroglycerin (PDF - 132KB)DraftTransdermalFilm, Extended Release2014512/2009
Nitroglycerin (PDF - 132KB)DraftTransdermalFilm, Extended Release7455912/2009
Norethindrone (PDF - 16KB)DraftOralTablet1706010/2009
Norethindrone (PDF - 16KB)DraftOralTablet169544/2009
Norethindrone Acetate (PDF - 16KB)DraftOralTablet184053/2009

 Nortriptyline HCl (PDF - 38KB)

DraftOralCapsule0180139/2015
Nystatin (PDF - 30KB)DraftOralSuspension 6251211/2010
Nystatin (PDF - 29KB)DraftTopicalCream640225/2010
Nystatin (PDF - 29KB)DraftTopicalOintment621245/2010
Nystatin (PDF - 28KB)DraftTopicalPowder652035/2010

 

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