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) | Draft | Oral | Tablet | 202379 | 12/2012 |
| 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 | 88616 89451 40496 | 3/2010 |
| Acetaminophen; Caffeine; Dihydrocodeine Bitartrate (PDF - 44 KB) | Final | Oral | Tablet | 40316 40109 | 10/2011 |
| Acetaminophen; Hydrocodone Bitartrate (PDF - 17 KB) | Draft | Oral | Tablet | 88058 89699 81223 40100 40148 40099 40094 | 12/2009 |
| Acetaminophen; Oxycodone HCl (PDF - 17 KB) | Draft | Oral | Tablet | 40341 40330 40434 | 12/2009 |
| Acetaminophen; Propoxyphene Napsylate | Draft | Oral | Tablet | 17122 76429 76743 | 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) | Draft | Oral | Capsule | 19821 | 5/2007 |
| 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 - 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 | 70589 | 12/2010 |
| Amantadine HCl (PDF - 47KB) | Draft | Oral | Tablet | 76186 | 1/2011 |
| Ambrisentan (PDF - 16 KB) | Draft | Oral | Tablet | 22081 | 8/2009 |
| 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) | Final | Oral | Capsule | 20364 | 5/2008 |
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 - 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) | Draft | Oral | Tablet | 11522 | 12/2008 |
| 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 |
| 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 |
| 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 |
| 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 |
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 |
