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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 '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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
Gabapentin (PDF - 14KB) Draft  Oral Tablet 22544 12/2012
Gabapentin (PDF - 32KB) Draft Oral Capsule 20235 5/2007
Gabapentin (PDF - 55KB) Final Oral Tablet 20882 5/2008
 Gabapentin Enacarbil (PDF - 47KB)  Draft  Oral Tablet, Extended Release 22399 6/2012

Galantamine HBr (PDF - 36KB)

Draft Oral Tablet 21169 11/2010
Galantamine HBr (PDF - 43KB) Draft Oral Capsule, Extended Release 21615 5/2007
Ganciclovir (PDF - 17KB) Draft Oral Capsule 19661 8/2007
Gatifloxacin 0.3% (PDF - 15KB) Draft Ophthalmic Solution 21493 7/2008
Gemfibrozil (PDF - 16KB) Draft Oral Tablet 18422 12/2009
Gemifloxacin Mesylate (PDF - 56KB) Final Oral Tablet 21158 5/2008
Glimepiride (PDF - 56KB) Final Oral Tablet 20496 5/2008
Glimepiride; Pioglitazone HCl (PDF - 34KB) Final Oral Tablet 21925 10/2011
Glimepiride; Rosiglitazone Maleate (PDF - 19KB) Draft Oral Tablet 21700 11/2007
Glipizide (PDF - 35KB) Draft Oral Tablet 17783 8/2010
Glipizide (PDF - 19KB) Draft Oral Tablet, Extended-Release 20329 7/2008
Glipizide; Metformin HCl (PDF - 49KB) Final Oral Tablet 21460 5/2008
Glyburide (PDF - 40KB) Draft  Oral Tablet 20051  3/2012
Glyburide (PDF - 40KB) Draft Oral Tablet

74388

17532

3/2012
Glyburide; Metformin HCl (PDF - 17KB)  Revised Final Oral Tablet 21178 12/2009
Glycopyrrolate (PDF - 15KB) Draft Oral Tablet 12827 11/2009
Goserelin Acetate (PDF - 16KB) Draft Subcutaneous Implant

20578

19726

10/2008
Granisetron (PDF - 424KB) Draft Transdermal Film, Extended Release 22198 3/2012
Granisetron HCl (PDF - 38KB) Revised Final Oral Tablet 78080 12/2010
Griseofulvin, Microcystalline (PDF - 34KB) Draft Oral Suspension 62483 11/2010
Griseofulvin, Microcrystalline (PDF - 25KB) Draft Oral Tablet 62279 2/2010
Griseofulvin, Ultramicrocrystalline (PDF - 16KB) Draft Oral Tablet 50475 10/2008

Guaifenesin (PDF - 22KB)

Draft Oral Tablet, Extended Release 21282 4/2014
Guaifenesin; Pseudoephedrine HCl (PDF - 18KB) Draft Oral Tablet, Extended Release 21585 12/2008

Guanfacine HCl (PDF - 32KB)

Draft Oral Tablet, Extended Release 22037 7/2010