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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 1153]
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 - April 2014 (26 New) 21 Revision February 2014) updated 4/2/2014

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

 

 Amphotericin B (PDF - 37KB)

 Draft InjectionLiposome507404/2014

Atorvastatin, Ezetimibe (PDF - 27KB)

 Draft OralTablet2001534/2014

Axitinib (PDF - 46KB)

 Draft OralTablet2023244/2014

Brinzolamide (PDF - 85KB)

DraftOphthalmicSuspension/Drops

20816

4/2014

Buprenorphine HCl; Naloxone HCl (PDF - 26KB)

Draft SublingualFilm0224104/2014

Buprenorphine (PDF - 145KB)

DraftTransdermalFilm, Extended Release

21306

4/2014

Clobazam (PDF - 25KB)

Draft OralSuspension2039934/2014
Desoximetasone (PDF - 25KB)DraftTopicalCream

073210

073193

4/2014

Desoximetasone (PDF - 42KB)

DraftTopicalOintment18594

74286

4/2014

Diazoxide (PDF - 22KB)

DraftOralSuspension174534/2014

Erythromycin (PDF - 23KB)

Draft OralTablet, Delayed Release622984/2014

Estradiol (PDF - 157KB)

DraftTransdermalFilm, Extended Release2037524/2014

Fentanyl Citrate (PDF - 29KB)

DraftNasalSpray, Metered225694/2014

Guaifenesin (PDF - 22KB)

DraftOralTablet, Extended Release212824/2014

Hydrochlorothiazide/Metoprolol Succinate (PDF - 23KB)

Draft OralTablet, Extended Release219564/2014

Levonorgestrel (PDF - 43KB)

DraftIntrauterineDevice, Intrauterine 13.5 mg.2031594/2014

Levonorgestrel (PDF - 43KB)

DraftIntrauterineDevice, Intrauterine 52 mg.212254/2014
Linagliptin/Metformin HCl (PDF - 25KB)DraftOralTablet2012814/2014
Mesalamine (PDF - 44KB)DraftOralCapsule, Delayed Release2044124/2014
Perampanel (PDF - 21KB)DraftOralTablet2028344/2014
Pindolol (PDF - 23KB)DraftOralTablet740194/2014
Prednisolone Acetate (PDF - 69KB)DraftOphthalmicSuspension/Drops170114/2014
Rabeprazole Sodium (PDF - 27KB)DraftOralCapsule, Delayed Release2047364/2014
Teriflunomide (PDF - 35KB)DraftOralTablet2029924/2014
Tranylcypromine Sulfate (PDF - 24KB)DraftOralTablet123424/2014
Verteporfin (PDF - 43KB)DraftInjection, IntravenousLiposome211194/2014

 

Newly Revised Bioequivalence Recommendations February 2014

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

 

Abiraterone Acetate (PDF - 21KB) Revised

 Draft OralTablet202379 2/2014
Amlodipine Besylate; Benazepril HCl (PDF - 46 KB) RevisedFinalOralCapsule203642/2014
Brimonidine Tartrate (PDF - 86KB)DraftOphthalmicSolution/Drops 0.1%

21770

2/2014
Brimonidine Tartrate (PDF - 87KB)DraftOphthalmicSolution/Drops 0.2%

76260

2/2014
Brimonidine Tartrate (PDF - 87KB)DraftOphthalmicSolution/Drops 0.15%

21262

2/2014
Buprenorphine HCl (PDF - 36KB) RevisedDraftOralTablet, Sublingual786332/2014
Doxycycline Hyclate (PDF-19KB) RevisedDraftOralTablet, Delayed Release507952/2014
Dronabinol (PDF-25KB) RevisedDraftOralCapsule186512/2014
Dutasteride;Tamsulosin HCl (PDF -62KB) RevisedDraft OralCapsule0224602/2014
Icosapent Ethyl (PDF - 83KB) RevisedDraftOralCapsule2020572/2014
Leuprolide Acetate (PDF - 44KB) RevisedDraftInjectableInjection

19732 

20011 

20263 

2/2014
Leuprolide Acetate (PDF - 40KB) RevisedDraftInjectableInjection

20517 

20708 

2/2014
Metoprolol Succinate (PDF - 29KB)
Revised
DraftOralTablet, Extended Release199622/2014
Morphine Sulfate (PDF - 23KB)
Revised
DraftOralCapsule, Extended Release206162/2014
Mycophenolate Mofetil (PDF - 14KB)n RevisedDraftOralSuspension507592/2014
Mycophenolate Mofetil (PDF - 18KB) RevisedDraftOralCapsule507222/2014
Mycophenolate Mofetil HCl (PDF - 18KB) RevisedDraftOralTablet507232/2014
Mycophenolic Acid (PDF - 15KB) RevisedDraftOralTablet, Delayed Release507912/2014
Naltrexone (PDF - 17KB) RevisedDraftIntramuscularSuspension, Extended Release218972/2014
Octreotide Acetate (PDF - 34KB) RevisedDraftInjectionInjectable210082/2014
Triptorelin Pamoate (PDF - 15KB) RevisedDraftIntramuscularInjectable

20715

21288

2/2014