Drugs

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

Product-Specific Guidances 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

Naftifine HCl (PDF - 132KB) 

Draft Topical Cream 019599 1/2016

Naftifine HCl (PDF - 135KB)

Draft Topical Gel 204286 1/2016

Naloxegol oxalate (PDF -39KB)

Draft Oral Tablet 204760 6/2015

Naloxone HCl (PDF - 47KB)

Draft Nasal Spray 208411 4/2017
Naltrexone (PDF - 17KB)  Draft Intramuscular Suspension, Extended Release 21897 9/2015
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 - 22KB)

Draft Oral Capsule 21920 6/2015
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)  Draft Oral Tablet 21742 12/2014
Nelfinavir Mesylate (PDF - 52KB) Draft Oral Suspension 20778 11/2007
Nelfinavir Mesylate (PDF - 50KB) Final Oral Tablet

20779

21503
 

5/2008
Nepafenac (PDF - 73KB) Revised Draft Ophthalmic Drops, Suspension 0.1% 21862 12/2016
Nepafenac (PDF - 78KB)  Revised Draft Ophthalmic Drops, Suspension 0.3% 203491 12/2016

Netupitant; Palonosetron HCl (PDF - 52KB) 

Draft Oral Capsule 205718 9/2015
Nevirapine (PDF - 24KB) Revised Draft Oral Tablet, Extended Release 201152 7/2014
Nevirapine (PDF - 50KB) Final Oral Suspension 20933 5/2008
Nevirapine (PDF - 51KB) Revised Draft Oral Tablet 20636 5/2017
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)  Revised

Draft Transdermal Film, Extended Release 20076

 

20165

10/2016

Nicotine (PDF - 27KB)

Draft Nasal Spray, Metered 020385 1/2016

Nicotine polacrilex (PDF - 41KB)

Draft Oral Troche/lozenge 21330 12/2016

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)
Final Oral Tablet 20169 10/2011

Nintedanib esylate (PDF - 40KB)

Draft Oral Capsule 205832 9/2015
Nisoldipine (PDF - 38KB)
Revised
Draft Oral Tablet, Extended Release 079051 12/2014
Nisoldipine (PDF - 42KB)
Revised
Draft Oral Tablet, Extended Release 020356 3/2015
Nitazoxanide (PDF - 85KB) Final Oral Tablet 21497 10/2011

Nitisinone (PDF - 59KB)

Draft Oral Suspension 206356 12/2016
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 - 61KB)

Draft Sublingual Powder 208424 5/2017

Nitroglycerin  (PDF - 39KB)

Draft Transdermal Ointment 087355 6/2015
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 - 154KB) Revised  Draft Transdermal Film, Extended Release 20145 10/2016
Nitroglycerin (PDF - 158KB)  Revised Draft Transdermal Film, Extended Release 20144 10/2016
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

Nortriptyline HCl (PDF - 38KB)

Draft Oral Capsule 018013 9/2015
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

Nystatin and Triamcinolone acetonide (PDF - 91KB)

Draft Topical Cream 062364 5/2017

Nystatin and Triamcinolone acetonide (PDF - 33KB)

Draft Topical Ointment 063305 5/2017

 

Page Last Updated: 09/07/2017
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