• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

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 1208]
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 - July 2014 (41 New) 15 Revisions updated 11/3/2014

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

 

 Alogliptin Benzoate (PDF - 23KB)

 Draft OralTablet222717/2014

 Alogliptin Benzoate; Metformin HCl(PDF - 23KB)

 Draft OralTablet2034147/2014

 Alogliptin Benzoate; Pioglitazone HCl (PDF - 22KB)

 Draft OralTablet224267/2014

 Amoxicillin (PDF - 23KB)

DraftOralSuspension

061931

7/2014

 Amoxicillin (PDF - 23KB)

DraftOralSuspension0651197/2014

 Atenolol and Chlorthalidone (PDF - 22KB)

DraftOralTablet

018760

7/2014

 Canagliflozin (PDF - 24KB)

Draft OralTablet2040427/2014

 Carbidopa (PDF - 23KB)

DraftOralTablet0178307/2014

 Carbinoxamine Maleate (PDF -26KB)

DraftOralSuspension, Extended Release225567/2014

Cefixime  (PDF - 23KB)

DraftOralTablet, Chewable653807/2014

Colestipol Hydrochloride (PDF - 26KB)

Draft OralTablet202227/2014

Crizotinib (PDF -44KB)

DraftOralCapsule2025707/2014

Daunorubicin citrate (PDF - 83KB)

DraftIntravenousInjection, Liposome507047/2014

Diflorasone Diacetate (PDF - 22KB)

DraftTopicalOintment0753317/2014

Dimethyl Fumarate (PDF - 24KB)

DraftOralCapsule, Delayed Release2040637/2014

Diphenhydramine HCl (PDF -23KB)

DraftOralCapsule.0807387/2014

Doxycycline (PDF - 42KB)

DraftOralCapsule0506417/2014
Doxycycline (PDF - 42KB)DraftOralCapsule0650557/2014

Doxylamine Succinate; Pyridoxine HCl (PDF - 27KB) 

DraftOralTablet, Delayed Release218767/2014

Esomeprazole Strontium (PDF - 62KB)

DraftOralCapsule, Delayed Release2023427/2014

Ethinyl Estradiol; Levonorgestrel (PDF -41KB)

DraftOralTablet2040617/2014

Ethinyl Estradiol; Norethindrone (PDF - 22KB)

DraftOralTablet, Chewable2036677/2014

Fosfomycin Tromethamine (PDF - 20KB)

DraftOralSuspension507177/2014

Gentamicin Sulfate (PDF -18KB)

DraftOphthalmicSolution0640487/2014

Hydromorphone HCl (PDF - 44KB)

DraftOralTablet, Extended Release0212177/2014

Lanreotide Acetate (PDF - 21KB)

DraftSubcutaneousInjection220747/2014

Linagliptin; Metformin HCl (PDF -25KB) 

DraftOralTablet2012817/2014

Lomustine (PDF - 31KB) 

DraftOralCapsule0175887/2014

Menthol; Methyl Salicylate (PDF -158KB)

DraftTopicalPatch220297/2014

Ospemifene (PDF - 22KB) 

DraftOralTablet2035057/2014

Oxcarbazepine (PDF- 27KB)

DraftOralTablet, Extended Release2028107/2014

Paroxetine Mesylate (PDF - 20KB)

DraftOralCapsule2045167/2014

Promethazine HCl  (PDF - 22KB) 

DraftRectalSuppository0404287/2014

Promethazine HCl (PDF - 22KB)

DraftRectalSuppository0871657/2014

Propranolol HCl (PDF - 25KB)

DraftOralCapsule, Extended Release0185537/2014

Ropinirole HCl (PDF - 24KB)

DraftOralTablet, Immediate Release0206587/2014

Metformin HCl; Sitagliptin Phosphate (PDF - 26KB)

DraftOralTablet, Extended Release2022707/2014

Sucralfate (PDF - 81KB)

DraftOralSuspension191837/2014

Sucralfate  (PDF - 81KB)

DraftOralTablet183337/2014

Tacrolimus (PDF - 32KB)

DraftOralCapsule, Extended Release2040967/2014

Zolmitriptan  (PDF - 26KB)

DraftNasalSpray0214507/2014

 

Newly Revised Bioequivalence Recommendations July 2014

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

Dronedarone Hydrochoride (PDF - 62KB)Revised

DraftOralTablet224257/2014
Duloxetine HCl (PDF-57KB) RevisedDraftOralCapsule, Delayed Release Pellets214277/2014

Ergocalciferol (PDF - 46KB) Revised

DraftOralCapsule034447/2014
Esomeprazole Magnesium (PDF - 55KB) RevisedDraftOralCapsule, Delayed Release Pellets211538/2014
Fluorouracil (PDF - 168KB) RevisedDraftTopicalCream209857/2014
Hydrochlorothiazide; Moexipril HCl (PDF - 27KB) RevisedDraftOralTablet207297/2014
Imatinib Mesylate (PDF - 31KB)  RevisedDraftOralTablet215887/2014
Lansoprazole (PDF - 37KB)RevisedDraftOralCapsule, Delayed Release204067/2014
Lidocaine (PDF - 147KB)RevisedDraftTopicalPatch206127/2014
Mesalamine (PDF - 66KB)RevisedDraftOralCapsule, Extended Release200497/2014
Mesalamine (PDF - 65KB)RevisedDraft OralCapsule, Extended Release223017/2014
 

Methylphenidate HCl (PDF - 80KB)

Draft OralTablet, Extended Release2112111/2014
Nevirapine (PDF - 24KB)RevisedDraftOralTablet, Extended Release2011527/2014
Nilotinib HCl Monohydrate (PDF - 19KB)RevisedDraftOralCapsule220687/2014
 Pentosan Polysulfate Sodium (PDF - 90KB)RevisedDraft OralCapsule201937/2014