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U.S. Department of Health and Human Services

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Bioequivalence Recommendations for Specific Products

 

"Please submit comments for any of the guidances posted in the Bioequivalence Recommendations for Specific Products website to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments refer to the website http://www.regulations.gov OR you can mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov HelpDesk at 1-877-378-5457 (toll free) for assistance regarding submissions."

 

Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient [Total count 1099]
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


 

Newly Added Recommendations - March/April 2013 ( 31 New;  13 Revision) updated 4/29/2013 

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 

 

 

Albuterol Sulfate (PDF - 144KB)

 Draft InhalationAerosol, Metered

20503

20983

21457

 4/2013

Amoxicillin (PDF - 25KB)

 Draft Oral Tablet, Extended Release50813 4/2013
Bupropion HCl (PDF - 34KB)DraftOralTablet, Extended-Release224973/2013

 

Cefixime (PDF - 22KB)

 Draft Oral Capsule2031954/2013

 

Desipramine HCl (PDF -22KB)

DraftOralTablet

14399

4/2013

 

 

Desvenlafaxine (PDF - 25KB)

DraftOralTablet, Extended Release

204150

4/2013
Dutasteride;Tamsulosin HCl (PDF -62KB)Draft OralCapsule0224604/2013
Estramustine Phosphate Sodium (PDF - 24KB)Draft OralCapsule0180454/2013
Ethinyl Estradiol; Etonogestrel (PDF - 22KB)Draft VaginalRing211874/2013

 

Ethionamide (PDF - 22KB) 

DraftOralTablet

13026

4/2013

 

Ezogabine (PDF - 21KB)

Draft OralTablet223454/2013
Flutamide (PDF - 23KB)DraftOralCapsule0757804/2013
Hydrocortisone (PDF - 22KB)DraftOralTablet086974/2013
Icosapent Ethyl (PDF - 83KB)DraftOralCapsule, Gel2020574/2013
Ketorolac Tromethamine (PDF - 25KB)DraftNasalSpray, Metered223824/2013
Loratadine (PDF - 22KB)DraftOralCapsule0219524/2013
Metronidazole (PDF - 112KB)DraftVaginalGel

20208

21806
4/2013
Miconazole (PDF - 63KB)DraftBuccalTablet224044/2013
Minocycline HCl (PDF - 24KB)DraftOralCapsule, Extended Release2019224/2013
Mitotane (PDF -21KB)DraftOralTablet0168854/2013
Nevirapine (PDF - 24KB)DraftOralTablet, Extended Release2011524/2013
Rimexolone (PDF - 21KB)DraftOphthalmicDrops, Suspension0204744/2013
Rizatriptan Benzoate (PDF - 21KB)DraftOralTablet, Orally Disintegrating208654/2013
Silodosin (PDF - 24KB)DraftOralCapsule222064/2013
Testosterone (PDF -27KB)1%DraftTransdermalGel, Metered210154/2013
Testosterone (PDF - 27KB) 1.62%DraftTransdermalGel, Metered223094/2013
Testosterone (PDF - 26KB) 10 mg/0.5 gm gelDraftTransdermalGel, Metered214634/2013
Testosterone (PDF - 27KB)1%DraftTransdermalGel210154/2013
Testosterone (PDF - 27KB) 1%DraftTransdermalGel214544/2013
Testosterone (PDF - 27KB) 1.62%DraftTransdermalGel223094/2013
Testosterone (PDF - 21KB)DraftTransdermalSolution, Metered225044/2013
Zolpidem Tartrate (PDF - 25KB)DraftOralSpray0221964/2013

 

Revisions           
Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Bupropion HBr (PDF - 21KB)
Revised
DraftOralTablet, Extended Release221083/2013
Bupropion HCl (PDF - 34KB)RevisedDraftOralTablet186443/2013
Bupropion HCl (PDF - 22KB) Revised
 
DraftOralTablet, Extended Release215153/2013
Bupropion HCl (PDF - 34KB)RevisedDraftOralTablet, Extended-Release

20358

20711

3/2013
Cefixime (PDF - 18KB)RevisedDraftOralSuspension

65129

65355

202091

4/2013
Darunavir Ethanolate (PDF-49KB) RevisedDraftOralTablet219764/2013
Dextromethorphan Hydrobromide; Quinidine Sulfate (PDF - 39KB)Revised Draft OralCapsule21879 4/2013
Imatinib Mesylate (PDF - 31KB)RevisedFinalOralTablet215884/2013
Loteprednol Etabonate (PDF - 58KB)RevisedDraftOphthalmicDrops, suspension

20583

4/2013
Mesalamine (PDF - 35KB)RevisedDraftRectalSuppository212523/2013

 

 

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