Drugs

Bioequivalence Recommendations for Specific Products: Active Ingredients Starting with 'A'

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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
Abacavir Sulfate (PDF - 84 KB)FinalOralTablet209775/2008
Abacavir Sulfate; Lamivudine (PDF - 98 KB)DraftOralTablet2165211/2007
Abacavir Sulfate; Lamivudine; Zidovudine (PDF - 175 KB)FinalOralTablet212055/2008

 

Abiraterone Acetate (PDF - 21KB) Revised

 Draft OralTablet202379 2/2014
Acamprosate Calcium (PDF - 76 KB)FinalOralTablet, Delayed Release214315/2008
Acarbose (PDF - 37 KB)DraftOralTablet204827/2009
Acetaminophen (PDF - 33KB)DraftOralTablet, Extended Release198722/2011
Acetaminophen; Butalbital(PDF-17 KB)DraftOralCapsule

88831 

3/2010
Acetaminophen; Butalbital (PDF-17 KB)DraftOralTablet

89988 

 

3/2010
Acetaminophen; Butalbital; Caffeine (PDF-17 KB)DraftOralCapsule

89007 

40085 

40885

3/2010
Acetaminophen; Butalbital; Caffeine (PDF-17 KB)DraftOralTablet

89451 

40496

3/2010
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate (PDF - 44 KB)FinalOralTablet

40109

10/2011
Acetaminophen; Hydrocodone Bitartrate (PDF - 17 KB)DraftOralTablet

89699

81223

40100

40148

40099

40094

12/2009
Acetaminophen; Oxycodone HCl (PDF - 17 KB)DraftOralTablet

40330

40434

12/2009

 

Acetaminophen; Propoxyphene NapsylateDraftOralTablet

76429 

2/2010
Acetaminophen; Tramadol HCl (PDF - 42 KB)nFinalOralTablet211235/2008
Acetazolamide (PDF-18 KB)DraftOralCapsule, Extended Release129452/2010
Acetazolamide (PDF - 17 KB)DraftOralTablets401957/2008
Acitretin (PDF - 131 KB) RevisedDraftOralCapsule1982111/2013
Acyclovir (PDF - 39KB)DraftOralCapsule18828 3/2012
Acyclovir (PDF - 176KB)DraftTopicalOintment18604 3/2012
Acyclovir (PDF - 51 KB)FinalOralTablet200895/2008
Adapalene (PDF - 197KB)DraftTopicalLotion225022/2011
Adapalene(PDF - 88 KB)DraftTopicalCream2074811/2009
Adapalene (PDF - 88 KB)DraftTopicalGel2038011/2009
Adapalene (PDF - 88 KB)DraftTopicalGel2175311/2009
Adapalene; Benzoyl Peroxide (PDF - 88 KB)DraftTopicalGel2232011/2009
Adefovir Dipivoxil (PDF - 21 KB)DraftOralTablet214497/2008

Albendazole (PDF - 24KB)

 Draft Oral Tablet20666 12/2012

 

Albuterol Sulfate (PDF - 144KB) Revised

 Draft InhalationAerosol, Metered

20503

20983

21457

 6/2013
Albuterol Sulfate (PDF - 15 KB)DraftOralTablet728948/2008
Alendronate Sodium (PDF - 39 KB) RevisedDraftOralTablet2056010/2011
Alendronate Sodium and Cholecalciferol (PDF - 50 KB) RevisedDraftOralTablet2176210/2011
Alfuzosin HCl (PDF - 74 KB)DraftOralTablet, Extended Release2128711/2007
Aliskiren Hemifumarate (PDF - 16 KB)DraftOralTablet219858/2009
Aliskiren Hemifumarate; Amlodipine Besylate(PDF - 86KB) Draft OralTablet22545 6/2012
Aliskiren Hemifumarate; Hydrochlorothiazide (PDF - 16 KB)DraftOralTablet221078/2009
Aliskiren Hemifumarate; Valsartan (PDF - 38KB)DraftOralTablet222173/2011
Allopurinol (PDF - 16 KB)DraftOralTablet160844/2009
Almotriptan Malate (PDF - 54 KB)FinalOralTablet210015/2008

 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
Alosetron HCl (PDF - 45 KB)FinalOralTablet211075/2008
Alprazolam (PDF - 16 KB)DraftOralTablet, Orally Disintegrating217269/2008
Alprazolam (PDF - 76 KB)DraftOralTablet, Extended Release2143411/2007
Alprazolam (PDF - 16 KB)
Revised
DraftOralTablet182769/2008
Altretamine (PDF - 30KB)DraftOralCapsule199264/2010
 Alvimopan (PDF - 43KB) Draft OralCapsule21775  6/2012
Amantadine HCl (PDF - 32KB)DraftOralCapsule7129312/2010
Amantadine HCl (PDF - 47KB)DraftOralTablet761861/2011
Ambrisentan (PDF - 16 KB) RevisedDraftOralTablet220816/2013
Amiloride (PDF - 41KB) Draft OralTablet70346 3/2012
Aminosalicylic Acid (PDF - 17 KB)DraftOralGranules, Delayed Release743467/2008

Amiodarone HCl (PDF - 38KB)

DraftOralTablet

18972

12/2010
Amitriptyline HCl (PDF-18 KB)DraftOralTablet

85966 

85969 

85968 

85971 

85967 

85970 

3/2010
Amlodipine Besylate (PDF - 44 KB)FinalOralTablet197875/2008
Amlodipine Besylate; Atorvastatin Calcium (PDF - 19 KB)DraftOralTablet215405/2009
Amlodipine Besylate; Benazepril HCl (PDF - 46 KB) RevisedFinalOralCapsule203642/2014

 

Amlodipine Besylate, Hydrochlorothiazide, Olmesartan Medoxomil (PDF - 25KB)

 Draft Oral Tablet20017512/2012
Amlodipine Besylate; Olmesartan Medoxomil (PDF - 16 KB)DraftOralTablet2210010/2008

Amlodipine Besylate; Telmisartan (PDF - 36KB)

DraftOralTablet224018/2010
Amlodipine Besylate; Valsartan (PDF - 24 KB)DraftOralTablet219908/2008
Amlodipine; Hydrochlorothiazide; Valsartan (PDF - 22KB)DraftOralTablet223144/2010

 Amoxicillin (PDF - 23KB)

DraftOralSuspension

061931

7/2014

 Amoxicillin (PDF - 23KB)

DraftOralSuspension0651197/2014

Amoxicillin (PDF - 25KB)

 Draft Oral Tablet, Extended Release50813 4/2013

Amoxicillin (PDF - 21KB)

 Draft Oral Capsule061926 9/2012

 

Amoxicillin; Clavulanate Potassium (PDF - 17KB)

 Draft Oral Suspension50575 9/2012

Amoxicillin; Clavulanate Potassium (PDF - 33KB)

DraftOralTablet

50720

50564

11/2010
Amoxicillin; Clavulanate Potassium (PDF - 54 KB)DraftOralTablet, Chewable505971/2008
Amoxicillin; Clavulanate Potassium (PDF - 54 KB)DraftOralTablet, Chewable507261/2008
Amoxicillin; Clavulanate Potassium (PDF - 74 KB)FinalOralSuspension50755
50725
5/2008
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate (PDF - 78KB) Draft Oral Capsule, Extended Release213039/2012
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate (PDF - 15 KB) RevisedDraftOralTablet4042211/2013

 Amphotericin B (PDF - 37KB)

 Draft InjectionLiposome507404/2014
Amprenavir (PDF - 21 KB)DraftOralCapsule210078/2008
Anagrelide HCl (PDF - 42 KB)FinalOralCapsule764685/2008
Anastrozole (PDF - 124 KB)FinalOralTablet205415/2008

 

 Apixaban (PDF - 22KB)

 Draft OralTablet2021556/2013
Aprepitant (PDF - 42 KB)FinalOralCapsule215495/2008
Aripiprazole (PDF - 27 KB)DraftOralTablet, Orally Disintegrating2172912/2009
Aripiprazole (PDF - 138 KB)DraftOralTablet2143611/2007
Armodafinil(PDF - 18 KB)DraftOralTablet218751/2008

 Artemether/Lumefantrine (PDF - 23KB)

 Draft Oral Tablet222686/2013

 Asenapine Maleate (PDF - 90KB)

 Draft Sublingual Tablet221176/2013
Aspirin; Butalbital; Caffeine (PDF-17 KB)DraftOralCapsule175343/2010
Aspirin; Butalbital; Caffeine (PDF-17 KB)DraftOralTablet861623/2010
Aspirin; Butalbital; Caffeine; Codeine Phosphate (PDF - 16 KB)DraftOralCapsule1942912/2009
Aspirin; Dipyridamole (PDF-18 KB)DraftOralCapsule, Extended Release208843/2010
Aspirin; Oxycodone HCl and Aspirin;Oxycodone Terephthalate (PDF - 26KB)DraftOralTablet073372/2010
Atazanavir Sulfate (PDF - 42 KB)FinalOralCapsule215675/2008
Atenolol (PDF - 16 KB)DraftOralTablet1824011/2009

 Atenolol and Chlorthalidone (PDF - 22KB)

DraftOralTablet

018760

7/2014
Atomoxetine HCl(PDF - 51 KB)FinalOralCapsule214115/2008
Atorvastatin Calcium (PDF - 46 KB) RevisedFinalOralTablet2070210/2010

Atorvastatin, Ezetimibe (PDF - 27KB)

 Draft OralTablet2001534/2014
Atovaquone (PDF - 18 KB)DraftOralSuspension2050012/2009
Atovaquone (PDF - 111 KB)DraftOralTablet2025911/2007
Atovaquone; Proguanil(PDF - 16 KB)DraftOralTablet210787/2008
Auranofin (PDF-26 KB)DraftOralCapsule186892/2010

Axitinib (PDF - 46KB)

 Draft OralTablet2023244/2014
Azacitidine (PDF - 16 KB)
Revised
DraftSubcutaneousInjection5079411/2012
Azathioprine (PDF - 44KB)DraftOralTablet163249/2010
Azelaic Acid (PDF - 212KB)DraftTopicalCream204285/2010
Azelaic Acid (PDF - 181KB)RevisedDraftTopicalGel214709/2012
 Azilsartan Medoxomil (PDF - 41KB)
 
 Draft OralTablet200796  6/2012
Azithromycin (PDF - 16 KB)DraftOralSuspension5071012/2008
Azithromycin (PDF - 20 KB)DraftOralSuspension, Extended Release507977/2008
Azithromycin (PDF - 19 KB)DraftOralTablet50730
50711
50784
1/2008

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