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U.S. Department of Health and Human Services

Drugs

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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)
Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)
Date
Recommended
Abacavir Sulfate (PDF - 84 KB) Final Oral Tablet 20977 5/2008
Abacavir Sulfate; Lamivudine (PDF - 98 KB) Draft Oral Tablet 21652 11/2007
Abacavir Sulfate; Lamivudine; Zidovudine (PDF - 175 KB) Final Oral Tablet 21205 5/2008

 

Abiraterone Acetate (PDF - 21KB) Revised

 Draft  Oral Tablet 202379  2/2014
Acamprosate Calcium (PDF - 76 KB) Final Oral Tablet, Delayed Release 21431 5/2008
Acarbose (PDF - 37 KB) Draft Oral Tablet 20482 7/2009
Acetaminophen (PDF - 33KB) Draft Oral Tablet, Extended Release 19872 2/2011
Acetaminophen; Butalbital(PDF-17 KB) Draft Oral Capsule

88831 

3/2010
Acetaminophen; Butalbital (PDF-17 KB) Draft Oral Tablet

89988 

 

3/2010
Acetaminophen; Butalbital; Caffeine (PDF-17 KB) Draft Oral Capsule

89007 

40085 

40885

3/2010
Acetaminophen; Butalbital; Caffeine (PDF-17 KB) Draft Oral Tablet

89451 

40496

3/2010
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate (PDF - 44 KB) Final Oral Tablet

40109

10/2011
Acetaminophen; Hydrocodone Bitartrate (PDF - 17 KB) Draft Oral Tablet

89699

81223

40100

40148

40099

40094

12/2009
Acetaminophen; Oxycodone HCl (PDF - 17 KB) Draft Oral Tablet

40330

40434

12/2009

 

Acetaminophen; Propoxyphene Napsylate Draft Oral Tablet

76429 

2/2010
Acetaminophen; Tramadol HCl (PDF - 42 KB)n Final Oral Tablet 21123 5/2008
Acetazolamide (PDF-18 KB) Draft Oral Capsule, Extended Release 12945 2/2010
Acetazolamide (PDF - 17 KB) Draft Oral Tablets 40195 7/2008
Acitretin (PDF - 131 KB) Revised Draft Oral Capsule 19821 11/2013
Acyclovir (PDF - 39KB) Draft Oral Capsule 18828  3/2012
Acyclovir (PDF - 176KB) Draft Topical Ointment 18604  3/2012
Acyclovir (PDF - 51 KB) Final Oral Tablet 20089 5/2008
Adapalene (PDF - 197KB) Draft Topical Lotion 22502 2/2011
Adapalene(PDF - 88 KB) Draft Topical Cream 20748 11/2009
Adapalene (PDF - 88 KB) Draft Topical Gel 20380 11/2009
Adapalene (PDF - 88 KB) Draft Topical Gel 21753 11/2009
Adapalene; Benzoyl Peroxide (PDF - 88 KB) Draft Topical Gel 22320 11/2009
Adefovir Dipivoxil (PDF - 21 KB) Draft Oral Tablet 21449 7/2008

Albendazole (PDF - 24KB)

 Draft  Oral  Tablet 20666  12/2012

 

Albuterol Sulfate (PDF - 144KB) Revised

 Draft  Inhalation Aerosol, Metered

20503

20983

21457

 6/2013
Albuterol Sulfate (PDF - 15 KB) Draft Oral Tablet 72894 8/2008
Alendronate Sodium (PDF - 39 KB) Revised Draft Oral Tablet 20560 10/2011
Alendronate Sodium and Cholecalciferol (PDF - 50 KB) Revised Draft Oral Tablet 21762 10/2011
Alfuzosin HCl (PDF - 74 KB) Draft Oral Tablet, Extended Release 21287 11/2007
Aliskiren Hemifumarate (PDF - 16 KB) Draft Oral Tablet 21985 8/2009
Aliskiren Hemifumarate; Amlodipine Besylate(PDF - 86KB)  Draft  Oral Tablet 22545  6/2012
Aliskiren Hemifumarate; Hydrochlorothiazide (PDF - 16 KB) Draft Oral Tablet 22107 8/2009
Aliskiren Hemifumarate; Valsartan (PDF - 38KB) Draft Oral Tablet 22217 3/2011
Allopurinol (PDF - 16 KB) Draft Oral Tablet 16084 4/2009
Almotriptan Malate (PDF - 54 KB) Final Oral Tablet 21001 5/2008
Alosetron HCl (PDF - 45 KB) Final Oral Tablet 21107 5/2008
Alprazolam (PDF - 16 KB) Draft Oral Tablet, Orally Disintegrating 21726 9/2008
Alprazolam (PDF - 76 KB) Draft Oral Tablet, Extended Release 21434 11/2007
Alprazolam (PDF - 16 KB)
Revised
Draft Oral Tablet 18276 9/2008
Altretamine (PDF - 30KB) Draft Oral Capsule 19926 4/2010
 Alvimopan (PDF - 43KB)  Draft  Oral Capsule 21775   6/2012
Amantadine HCl (PDF - 32KB) Draft Oral Capsule 71293 12/2010
Amantadine HCl (PDF - 47KB) Draft Oral Tablet 76186 1/2011
Ambrisentan (PDF - 16 KB) Revised Draft Oral Tablet 22081 6/2013
Amiloride (PDF - 41KB)  Draft  Oral Tablet 70346  3/2012
Aminosalicylic Acid (PDF - 17 KB) Draft Oral Granules, Delayed Release 74346 7/2008

Amiodarone HCl (PDF - 38KB)

Draft Oral Tablet

18972

12/2010
Amitriptyline HCl (PDF-18 KB) Draft Oral Tablet

85966 

85969 

85968 

85971 

85967 

85970 

3/2010
Amlodipine Besylate (PDF - 44 KB) Final Oral Tablet 19787 5/2008
Amlodipine Besylate; Atorvastatin Calcium (PDF - 19 KB) Draft Oral Tablet 21540 5/2009
Amlodipine Besylate; Benazepril HCl (PDF - 46 KB) Revised Final Oral Capsule 20364 2/2014

 

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

 Draft  Oral  Tablet 200175 12/2012
Amlodipine Besylate; Olmesartan Medoxomil (PDF - 16 KB) Draft Oral Tablet 22100 10/2008

Amlodipine Besylate; Telmisartan (PDF - 36KB)

Draft Oral Tablet 22401 8/2010
Amlodipine Besylate; Valsartan (PDF - 24 KB) Draft Oral Tablet 21990 8/2008
Amlodipine; Hydrochlorothiazide; Valsartan (PDF - 22KB) Draft Oral Tablet 22314 4/2010

Amoxicillin (PDF - 25KB)

 Draft  Oral  Tablet, Extended Release 50813  4/2013

Amoxicillin (PDF - 21KB)

 Draft  Oral  Capsule 061926  9/2012

 

Amoxicillin; Clavulanate Potassium (PDF - 17KB)

 Draft  Oral  Suspension 50575  9/2012

Amoxicillin; Clavulanate Potassium (PDF - 33KB)

Draft Oral Tablet

50720

50564

11/2010
Amoxicillin; Clavulanate Potassium (PDF - 54 KB) Draft Oral Tablet, Chewable 50597 1/2008
Amoxicillin; Clavulanate Potassium (PDF - 54 KB) Draft Oral Tablet, Chewable 50726 1/2008
Amoxicillin; Clavulanate Potassium (PDF - 74 KB) Final Oral Suspension 50755
50725
5/2008
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate (PDF - 78KB)  Draft  Oral  Capsule, Extended Release 21303 9/2012
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate (PDF - 15 KB) Revised Draft Oral Tablet 40422 11/2013

 Amphotericin B (PDF - 37KB)

 Draft  Injection Liposome 50740 4/2014
Amprenavir (PDF - 21 KB) Draft Oral Capsule 21007 8/2008
Anagrelide HCl (PDF - 42 KB) Final Oral Capsule 76468 5/2008
Anastrozole (PDF - 124 KB) Final Oral Tablet 20541 5/2008

 

 Apixaban (PDF - 22KB)

 Draft  Oral Tablet 202155 6/2013
Aprepitant (PDF - 42 KB) Final Oral Capsule 21549 5/2008
Aripiprazole (PDF - 27 KB) Draft Oral Tablet, Orally Disintegrating 21729 12/2009
Aripiprazole (PDF - 138 KB) Draft Oral Tablet 21436 11/2007
Armodafinil(PDF - 18 KB) Draft Oral Tablet 21875 1/2008

 Artemether/Lumefantrine (PDF - 23KB)

 Draft  Oral  Tablet 22268 6/2013

 Asenapine Maleate (PDF - 90KB)

 Draft  Sublingual  Tablet 22117 6/2013
Aspirin; Butalbital; Caffeine (PDF-17 KB) Draft Oral Capsule 17534 3/2010
Aspirin; Butalbital; Caffeine (PDF-17 KB) Draft Oral Tablet 86162 3/2010
Aspirin; Butalbital; Caffeine; Codeine Phosphate (PDF - 16 KB) Draft Oral Capsule 19429 12/2009
Aspirin; Dipyridamole (PDF-18 KB) Draft Oral Capsule, Extended Release 20884 3/2010
Aspirin; Oxycodone HCl and Aspirin;Oxycodone Terephthalate (PDF - 26KB) Draft Oral Tablet 07337 2/2010
Atazanavir Sulfate (PDF - 42 KB) Final Oral Capsule 21567 5/2008
Atenolol (PDF - 16 KB) Draft Oral Tablet 18240 11/2009
Atomoxetine HCl(PDF - 51 KB) Final Oral Capsule 21411 5/2008
Atorvastatin Calcium (PDF - 46 KB) Revised Final Oral Tablet 20702 10/2010

Atorvastatin, Ezetimibe (PDF - 27KB)

 Draft  Oral Tablet 200153 4/2014
Atovaquone (PDF - 18 KB) Draft Oral Suspension 20500 12/2009
Atovaquone (PDF - 111 KB) Draft Oral Tablet 20259 11/2007
Atovaquone; Proguanil(PDF - 16 KB) Draft Oral Tablet 21078 7/2008
Auranofin (PDF-26 KB) Draft Oral Capsule 18689 2/2010

Axitinib (PDF - 46KB)

 Draft  Oral Tablet 202324 4/2014
Azacitidine (PDF - 16 KB)
Revised
Draft Subcutaneous Injection 50794 11/2012
Azathioprine (PDF - 44KB) Draft Oral Tablet 16324 9/2010
Azelaic Acid (PDF - 212KB) Draft Topical Cream 20428 5/2010
Azelaic Acid (PDF - 181KB)Revised Draft Topical Gel 21470 9/2012
 Azilsartan Medoxomil (PDF - 41KB)
 
 Draft  Oral Tablet 200796   6/2012
Azithromycin (PDF - 16 KB) Draft Oral Suspension 50710 12/2008
Azithromycin (PDF - 20 KB) Draft Oral Suspension, Extended Release 50797 7/2008
Azithromycin (PDF - 19 KB) Draft Oral Tablet 50730
50711
50784
1/2008