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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'G'
- Drug-Related Guidances Main Page
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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 |
| 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 | 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 | 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; Pseudoephedrine HCl (PDF - 18KB) | Draft | Oral | Tablet, Extended Release | 21585 | 12/2008 |
| Draft | Oral | Tablet, Extended Release | 22037 | 7/2010 |
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