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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 '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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
Nabilone (PDF - 15KB)
Revised
Draft Oral Capsule 18677 7/2009
Nabumetone (PDF - 43KB) Final Oral Tablet 75189 5/2008
Nadolol (PDF - 28KB) Final Oral Tablet 18063 10/2011
Naftifine HCl (PDF -68KB) Draft Topical Cream 19599 3/2012
Naftifine HCl (PDF - 57KB) Draft Topical Gel 19356 3/2012
Naltrexone (PDF - 17KB) Revised Draft Intramuscular Suspension, Extended Release 21897 2/2014
Naltrexone HCl (PDF -17KB) Draft Oral Tablet

18932

76264

12/2009
Naproxen (PDF - 26KB) Draft Oral Tablet, Delayed Release 20067 2/2010
Naproxen (PDF - 16KB) Draft Oral Tablet 17581 7/2008
Naproxen Sodium (PDF - 17KB) Draft Oral Tablet, Extended Release 20353 4/2010
Naproxen Sodium (PDF - 16KB) Draft Oral Tablet 18164 7/2008
Naproxen Sodium (PDF - 16KB) Draft Oral Tablet 20204 7/2008
Naproxen Sodium; Sumatriptan Succinate (PDF - 29KB) Draft Oral Tablet 21926 8/2010
Naratriptan HCl (PDF - 16KB) Draft Oral Tablet 20763 7/2008
Nateglinide (PDF - 53KB) Final Oral Tablet 21204 5/2008
Nebivolol (PDF -36KB) Revised Draft Oral Tablet 21742 4/2011
Nelfinavir Mesylate (PDF - 52KB) Draft Oral Suspension 20778 11/2007
Nelfinavir Mesylate (PDF - 50KB) Final Oral Tablet

20779

21503
 

5/2008
Nevirapine (PDF - 24KB)Revised Draft Oral Tablet, Extended Release 201152 7/2014
Nevirapine (PDF - 50KB) Final Oral Suspension 20933 5/2008
Nevirapine (PDF - 51KB) Draft Oral Tablet 20636 11/2007
Niacin (PDF - 21KB)
Revised
Draft Oral Tablet, Extended Release 20381 12/2009
Niacin; Simvastatin (PDF - 42KB) Revised Draft Oral Tablet, Extended Release 22078 11/2011
Nicardipine HCl (PDF - 18KB) Draft Oral Capsule, Extended Release 20005 7/2008

Nicotine (PDF - 153KB)

Draft Transdermal Film, Extended Release 20076

 

20165

11/2013

Nicotine Polacrilex (PDF - 25KB)

Draft Buccal Chewing Gum 20066

18612

11/2013
Nicotine Polacrilex (PDF - 35KB) Draft Oral Lozenge 22360 1/2011
Nifedipine (PDF - 19KB) Draft  Oral Tablet, Extended Release 20198 9/2012
Nifedipine (PDF - 38KB) Draft Oral Capsule 18482 6/2011
Nifedipine (PDF - 30KB) Final Oral Tablet, Extended Release 19684 10/2011
Nilotinib HCl Monohydrate (PDF - 19KB)Revised Draft Oral Capsule 22068 7/2014
Nilutamide (PDF - 25KB)
Revised
Final Oral Tablet 20169 10/2011
Nisoldipine (PDF - 32KB) Final Oral Tablet, Extended Release 20356 10/2011
Nitazoxanide (PDF - 85KB) Final Oral Tablet 21497 10/2011
Nitrofurantoin (PDF - 26KB) Final Oral Suspension 09175 10/2011
Nitrofurantoin; Nitrofurantoin, Macrocrystalline (PDF - 24KB) Draft Oral Capsule 20064 3/2012
Nitrofurantoin Macrocrystalline (PDF - 31KB) Final Oral Capsule 16620 10/2011
Nitroglycerin (PDF - 19KB) Revised Draft Sublingual Aerosol, Metered 21780 2/2012
Nitroglycerin (PDF - 17KB)
Revised
Draft Sublingual Tablet 21134 2/2011
Nitroglycerin (PDF - 19KB) Revised Draft Oral/Sublingual Spray, Metered 18705 2/2012
Nitroglycerin (PDF - 132KB) Draft Transdermal Film, Extended Release 20145 12/2009
Nitroglycerin (PDF - 132KB) Draft Transdermal Film, Extended Release 74559 12/2009
Norethindrone (PDF - 16KB) Draft Oral Tablet 17060 10/2009
Norethindrone (PDF - 16KB) Draft Oral Tablet 16954 4/2009
Norethindrone Acetate (PDF - 16KB) Draft Oral Tablet 18405 3/2009
Nystatin (PDF - 30KB) Draft Oral Suspension  62512 11/2010
Nystatin (PDF - 29KB) Draft Topical Cream 64022 5/2010
Nystatin (PDF - 29KB) Draft Topical Ointment 62124 5/2010
Nystatin (PDF - 28KB) Draft Topical Powder 65203 5/2010