Drugs

Product-Specific Recommendations for Generic Drug Development: Active Ingredients starting with 'G'

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
Gabapentin (PDF - 14KB) RevisedDraft OralTablet225449/2015
Gabapentin (PDF - 32KB)DraftOralCapsule202355/2007
Gabapentin (PDF - 55KB)FinalOralTablet208825/2008
 Gabapentin Enacarbil (PDF - 47KB) Draft OralTablet, Extended Release223996/2012

Galantamine HBr (PDF - 36KB)

DraftOralTablet2116911/2010
Galantamine HBr (PDF - 43KB)DraftOralCapsule, Extended Release216155/2007
Ganciclovir (PDF - 17KB)DraftOralCapsule196618/2007
Gatifloxacin 0.3% (PDF - 15KB)DraftOphthalmicSolution214937/2008

Gefitinib (PDF - 39KB)

DraftOralTablet2069954/2016
Gemfibrozil (PDF - 16KB)DraftOralTablet1842212/2009
Gemifloxacin Mesylate (PDF - 56KB)FinalOralTablet211585/2008

Gentamicin Sulfate (PDF -18KB)

DraftOphthalmicSolution0640487/2014

 Glatiramer acetate (PDF - 51KB)

DraftSubcutaneousInjection206224/2016
Glimepiride (PDF - 56KB)FinalOralTablet204965/2008
Glimepiride; Pioglitazone HCl (PDF - 34KB)FinalOralTablet2192510/2011
Glimepiride; Rosiglitazone Maleate (PDF - 19KB)DraftOralTablet2170011/2007
Glipizide (PDF - 35KB)DraftOralTablet177838/2010
Glipizide (PDF - 19KB)DraftOralTablet, Extended-Release203297/2008
Glipizide; Metformin HCl (PDF - 49KB)FinalOralTablet214605/2008
Glyburide (PDF - 40KB)Draft OralTablet20051 3/2012
Glyburide (PDF - 40KB)DraftOralTablet

74388

17532

3/2012
Glyburide; Metformin HCl (PDF - 17KB)  RevisedDraftOralTablet2117812/2009
Glycopyrrolate (PDF - 15KB)DraftOralTablet1282711/2009
Goserelin Acetate (PDF - 16KB)DraftSubcutaneousImplant

20578

19726

10/2008
Granisetron (PDF - 424KB) RevisedDraftTransdermalFilm, Extended Release2219810/2016
Granisetron HCl (PDF - 38KB) RevisedFinalOralTablet7808012/2010
Griseofulvin, Microcystalline (PDF - 34KB)DraftOralSuspension6248311/2010
Griseofulvin, Microcrystalline (PDF - 25KB)DraftOralTablet622792/2010
Griseofulvin, Ultramicrocrystalline (PDF - 16KB)DraftOralTablet5047510/2008

Guaifenesin (PDF - 22KB)

DraftOralTablet, Extended Release212824/2014
Guaifenesin; Pseudoephedrine HCl (PDF - 18KB)DraftOralTablet, Extended Release2158512/2008

Guanfacine HCl (PDF - 32KB) Revised

DraftOralTablet, Extended Release220371/2016

 

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