Drugs

Product-Specific Guidances for Generic Drug Development Active Ingredient Starting with 'A'

Product-Specific Guidances 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; Dolutegravir sodium; Lamivudine  (PDF - 39KB)

 Draft  Oral Tablet 205551 6/2015
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  1/2016
Acamprosate Calcium (PDF - 76 KB) Revised Draft Oral Tablet, Delayed Release

21431

5/2008
Acarbose (PDF - 37 KB) Final Oral Tablet 20482 8/2017
Acetaminophen (PDF - 33KB) Draft Oral Tablet, Extended Release 19872 2/2011
Acetaminophen; Aspirin; Caffeine (PDF - 20KB) Final  Oral Tablet 020802 8/2017
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; Codeine phosphate (PDF - 20KB) Final  Oral

 

Capsule

20232 8/2017
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) Revised Draft Oral Tablet

89699

81223

40100

40148

40099

40094

6/2016

Acetaminophen; Oxycodone hydrochloride (PDF - 74KB)

 Draft  Oral

Tablet, Extended Release

204031 10/2016
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 008943 7/2008

Acetylcysteine  (PDF - 37KB)

 Draft Oral

Tablets, Effervescent

207916 5/2017
Acitretin (PDF - 131 KB)  Final Oral Capsule 19821 8/2017

 Aclidinium bromide (PDF - 97KB)

 Draft  inhalation powder, metered 202450 9/2015

Acyclovir (PDF - 47KB)

 Draft  Oral

 Tablet, buccal

203791 9/2015
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
Acyclovir  (PDF - 85KB) Revised  Draft  Topical Cream, 5% 021478 12/2016

Adapalene; Benzoyl peroxide (PDF - 159KB)

 Draft Topical

Gel

207917 12/2016
Adapalene (PDF - 197KB)  Revised Draft Topical Lotion 22502 12/2014
Adapalene(PDF - 88 KB) Revised Draft Topical Cream 20748 12/2014
Adapalene (PDF - 88 KB) Revised Draft Topical Gel 20380 12/2014
Adapalene (PDF - 88 KB) Revised Draft Topical Gel 21753 12/2014
Adapalene; Benzoyl Peroxide (PDF - 88 KB) Revised Draft Topical Gel 22320 12/2014
Adefovir Dipivoxil (PDF - 21 KB) Draft Oral Tablet 21449 7/2008

Afatinib dimaleate (PDF - 22KB)

 Draft  Oral

 Tablet

201292 6/2015

Albendazole (PDF - 40KB)

 Draft Oral  Tablet, Chewable 207844 4/2016

Albendazole (PDF - 24KB)

 Draft  Oral  Tablet 20666  12/2012

 

Albuterol Sulfate (PDF - 144KB) Revised

 Draft  Inhalation Aerosol, Metered

20503

20983

21457

 12/2016
Albuterol Sulfate (PDF - 15 KB) Revised Draft Oral Tablet 17853 6/2016

Alectinib hydrochloride (PDF - 63KB)

 Draft  Oral

Capsule

208434 10/2016

Alendronate sodium (PDF - 40KB)

 Draft  Oral Tablet, Effervescent 202344 6/2015
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

Alprostadil (PDF - 126KB)

 Draft Urethral  Suppository 020700 1/2016

Alogliptin Benzoate (PDF - 23KB)

 Draft  Oral Tablet 22271 7/2014

Alogliptin Benzoate; Metformin HCl(PDF - 23KB)

 Draft  Oral Tablet 203414 7/2014

Alogliptin Benzoate; Pioglitazone HCl (PDF - 22KB)

 Draft  Oral Tablet 22426 7/2014
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) Revised Draft Oral Capsule 16020 9/2015
Amantadine HCl (PDF - 47KB) Revised Draft Oral Tablet 18101 1/2011
Ambrisentan (PDF - 16 KB) Revised Draft Oral Tablet 22081 6/2013

Amcinonide (PDF -38KB) 

 Draft Topical  Lotion 76329 6/2016
Amiloride (PDF - 41KB)  Draft  Oral Tablet 18200  3/2012

Aminocaproic acid (PDF - 39KB)

 Draft  Oral Tablet 015197 9/2015
Aminosalicylic Acid (PDF - 17 KB) Draft Oral Granules, Delayed Release 18200 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 Draft 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; Perindopril arginine (PDF - 40KB) 

 Draft  Oral

 Tablet

205003 4/2016

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 - 23KB)

Final Oral Suspension

50460

8/2017

Amoxicillin (PDF - 23KB)

Final Oral Suspension 065119 8/2017

Amoxicillin (PDF - 25KB)

 Draft  Oral  Tablet, Extended Release 50813  4/2013

Amoxicillin (PDF - 21KB)

 Draft  Oral  Capsule 50459  9/2012

 

Amoxicillin; Clavulanate Potassium (PDF - 17KB)

 Draft  Oral  Suspension 50575  9/2012

Amoxicillin; Clavulanate Potassium (PDF - 33KB)

Final Oral Tablet

50720

50564

8/2017
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 (PDF - 71KB) 

 Draft  Oral

Suspension, Extended Release

208147 12/2016

Amphetamine (PDF - 59KB)

 Draft  Oral

Tablets,  Extended Release orally disintegrating

204326 5/2017
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 011522 11/2013

Amphotericin B (PDF - 37KB) Revised

 Draft  Injection Liposome 50740 1/2016
Amprenavir (PDF - 21 KB) Draft Oral Capsule 21007 8/2008
Anagrelide HCl (PDF - 42 KB) Final Oral Capsule 20333 5/2008
Anastrozole (PDF - 124 KB) Final Oral Tablet 20541 5/2008

 

Apixaban (PDF - 22KB) Revised

 Draft  Oral Tablet 202155 5/2017

Apremilast (PDF - 23KB)

Draft Oral Tablet 205437 9/2015
Aprepitant (PDF - 42 KB) Final Oral Capsule 21549 5/2008

Aprepitant (PDF - 38KB)

 Draft Oral Suspension 207865 5/2017
Aripiprazole (PDF - 27 KB) Draft Oral Tablet, Orally Disintegrating 21729 12/2009
Aripiprazole (PDF - 138 KB) Draft Oral Tablet 21436 11/2007
Aripiprazole  (PDF - 32KB) Draft Intramuscular Injectable Suspension, Extended Release

202971

4/2017
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 (PDF -KB)

Draft Oral Capsule 203697 6/2015

Aspirin (PDF - 42KB)

 Draft  Oral

Capsule,  Extended Release

200671 7/2017
Aspirin; Butalbital; Caffeine (PDF-17 KB) Final Oral Capsule 17534 8/2017
Aspirin; Butalbital; Caffeine (PDF-17 KB) Final Oral Tablet 17534 8/2017
Aspirin; Butalbital; Caffeine; Codeine Phosphate (PDF - 16 KB) Final Oral Capsule 19429 8/2017
Aspirin; Dipyridamole (PDF-18 KB) Draft Oral Capsule, Extended Release 20884 3/2010

Aspirin; Omeprazole (PDF - 46 KB

 Draft Oral

Tablets, Delayed release

205103 7/2017
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

Atazanavir Sulfate; Cobicistat (PDF - 39KB)

 Draft  Oral

 Tablet

206353 1/2016
Atenolol (PDF - 16 KB) Final Oral Tablet 18240 8/2017

Atenolol and Chlorthalidone (PDF - 22KB)

Final Oral Tablet

018760

8/2017
Atomoxetine HCl(PDF - 51 KB) Final Oral Capsule 21411 5/2008
Atorvastatin Calcium (PDF - 46 KB) Revised Draft 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
Avanafil (PDF - 40KB)  Draft  Oral Tablet 202276 3/2015

Axitinib (PDF - 46KB)

 Draft  Oral Tablet 202324 4/2014
Azacitidine (PDF - 16 KB)
Revised
Draft I.V. (infusion), Subcutaneous Powder 50794 4/2017
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

Azelastine hydrochloride  (PDF - 36KB)

Draft nasal Spray, metered 20114 5/2017

Azelastine HCl and fluticasone propionate (PDF - 78KB) Revised

Draft Nasal Spray, metered 202236 6/2016
Azilsartan kamedoxomil; chlorthalidone (PDF - 54KB)  Draft  Oral

 Tablet

Capsule

202331 3/2015
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

 

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