Drugs

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 1239]
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 - December 2014 (31 New) 22 Revisions updated 12/29/2014

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Acetaminophen; Aspirin; Caffeine (PDF - 20KB) Draft OralTablet02080212/2014
Acetaminophen; Butalbital; Caffeine; Codeine phosphate (PDF - 20KB) Draft Oral

 

Capsule

2023212/2014
Acyclovir  (PDF - 85KB) Draft TopicalCream, 5%02147812/2014
Aripiprazole  (PDF - 32KB)DraftIntramuscularInjectable Suspension, Extended Release

202971

12/2014
Benzyl alcohol (PDF - 135KB)DraftTopicalLotion02212912/2014
Betamethasone valerate (PDF - 45KB)DraftTopicalFoam, aerosol

20934

12/2014
Bosutinib monohydrate (PDF - 21KB)DraftOralTablet

203341

12/2014
Brimonidine tartrate; Brinzolamide (PDF - 85KB)Draft OphthalmicDrops, Suspension20425112/2014
Budesonide (PDF - 39KB)DraftOralTablet, Extended release

203634

12/2014
Buprenorphine HCl; Naloxone HCl (PDF - 23KB) 

 

DraftOralTablet, Sublingual20424212/2014
Cobicistat;Elvitegravir;Emtricitabine;Tenofovir disoproxil fumarate (PDF -24KB)DraftOralTablet20310012/2014
Conjugated estrogens (PDF - 223KB)DraftOralTablet00478212/2014
Dapsone (PDF - 103KB)Draft TopicalGel, 5%2179412/2014
Darunavir ethanolate (PDF - 20KB)DraftOralSuspension20289512/2014
Ibuprofen sodium  (PDF - 22KB)DraftOralTablet20180312/2014
Levothyroxine sodium (PDF - 31KB)DraftOralTablet

021116

021210

021301

021342

021402

12/2014

Lidocaine; Prilocaine (PDF - 19KB)

DraftTopicalCream01994112/2014
Lomitapide mesylate (PDF - 45KB)DraftOralCapsule.06231412/2014
Lurasidone HCl (PDF - 22KB)DraftOralTablet20060312/2014
Methylphenidate HCl (PDF - 33KB)Draft OralSuspension,Extended Release20210012/2014
Metoprolol tartrate (PDF - 22KB)DraftOralTablet07670412/2014
Nepafenac (PDF - 73KB)DraftOphthalmicDrops, Suspension 0.1%2186212/2014
Nepafenac (PDF - 78KB)DraftOphthalmicDrops, Suspension 0.3%20349112/2014
Posaconazole (PDF - 25KB)DraftOralTablet, Delayed Release20505312/2014
Raltegravir potassium (PDF - 25KB)DraftOralTablet, Chewable20304512/2014
Regorafenib (PDF - 22KB)DraftOralTablet20308512/2014
Selegiline hydrochloride (PDF - 49KB)DraftOralCapsule02064712/2014
Testosterone (PDF - 172KB)DraftTransdermalFilm, Extended Release02048912/2014
Tofacitinib citrate (PDF - 22KB)DraftOralTablet20321412/2014
Treprostinil diolamine (PDF - 41KB)DraftOralTablet, Extended Release20349612/2014
Vandetanib (PDF - 20KB)DraftOralTablet02240512/2014

 

Newly Revised Bioequivalence Recommendations Dec. 2014

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 
Adapalene (PDF - 197KB) RevisedDraftTopicalLotion2250212/2014
Adapalene(PDF - 88 KB) RevisedDraftTopicalCream20748122004
Adapalene (PDF - 88 KB) RevisedDraftTopicalGel2038012/2004
Adapalene (PDF - 88 KB) RevisedDraftTopicalGel2175312/2004
Adapalene; Benzoyl Peroxide (PDF - 88 KB)RevisedDraftTopicalGel2232012/2014
Brimonidine Tartrate (PDF - 86KB) RevisedDraftOphthalmicSolution/Drops 0.1%

21770

12/2014
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops 0.2%

76260

12/2014
Brimonidine Tartrate (PDF - 87KB) RevisedDraftOphthalmicSolution/Drops 0.15%

21262

12/2014

Brinzolamide (PDF - 85KB) Revised

DraftOphthalmicSuspension/Drops 1%

20816

12/2014
Doxorubicin HCl (PDF-66KB)RevisedDraftInjectableInjection, Liposome20326312/2014
Ethinyl Estradiol; Levonorgestrel (PDF -41KB) Revised

 

DraftOralTablet20406112/2014
Hydrocodone bitartrate; Ibuprofen (PDF - 18KB) RevisedDraftOralTablet02071612/2014
Ketoconazole (PDF - 43KB) RevisedDraftTopicalFoam, Aerosol 2%2173812/2014
Memantine HCl (PDF - 17KB)
Revised
DraftOralTablet2148712/2014
Memantine HCl (PDF - 27KB) RevisedDraftOralCapsule, Extended Release2252512/2014
Methylprednisolone Acetate (PDF - 29KB)   RevisedDraftInjectionSuspension1175712/2014
Nebivolol (PDF -36KB) RevisedDraftOralTablet2174212/2014
Nisoldipine (PDF - 38KB)
Revised
DraftOralTablet, Extended Release07905112/2014
Phenytoin sodium (PDF - 23KB) RevisedDraftOralCapsule, Extended Release04029812/2014
Phenytoin sodium (PDF - KB) RevisedDraftOralCapsule, Extended Release08434912/2014
Sevelamer Carbonate (PDF - 45KB) RevisedDraftOralSuspension2231812/2014
Sevelamer HCl (PDF - 44KB)
Revised
DraftOralTablet2117912/2014

 

 

Page Last Updated: 01/16/2015
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