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Drugs
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Individual Product Bioequivalence Recommendations: Active Ingredients Starting with 'A'
Individual Product Bioequivalence Recommendations 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 | Final | Oral | Tablet | 20977 | 5/2008 |
| Abacavir Sulfate; Lamivudine | Draft | Oral | Tablet | 21652 | 11/2007 |
| Abacavir Sulfate; Lamivudine; Zidovudine | Final | Oral | Tablet | 21205 | 5/2008 |
| Acamprosate Calcium | Final | Oral | Tablet, Delayed Release | 21431 | 5/2008 |
| Acarbose | Draft | Oral | Tablet | 20482 | 7/2009 |
| Acetaminophen; Caffeine; Dihydrocodeine Bitartrate | Draft | Oral | Tablet | 4/2009 | |
| Acetazolamide | Draft | Oral | Tablets | 40195 | 7/2008 |
| Acitretin | Draft | Oral | Capsule | 19821 | 5/2007 |
| Acyclovir | Final | Oral | Tablet | 20089 | 5/2008 |
| Adefovir Dipivoxil | Draft | Oral | Tablet | 21449 | 7/2008 |
| Albuterol Sulfate | Draft | Oral | Tablet | 72894 | 8/2008 |
| Alendronate Sodium | Draft | Oral | Tablet | 20560 | 1/2008 |
| Alendronate Sodium and Cholecalciferol | Draft | Oral | Tablet | 21762 | 4/2009 |
| Alfuzosin HCl | Draft | Oral | Tablet, Extended Release | 21287 | 11/2007 |
| Aliskiren Hemifumarate | Draft | Oral | Tablet | 21985 | 8/2008 |
| Aliskiren Hemifumarate | Draft | Oral | Tablet | 21985 | 8/2009 |
| Aliskiren Hemifumarate; Hydrochlorothiazide | Draft | Oral | Tablet | 22107 | 8/2009 |
| Allopurinol | Draft | Oral | Tablet | 16084 | 4/2009 |
| Almotriptan Malate | Final | Oral | Tablet | 21001 | 5/2008 |
| Alosetron HCl | Final | Oral | Tablet | 21107 | 5/2008 |
| Alprazolam | Draft | Oral | Tablet, Orally Disintegrating | 21726 | 9/2008 |
| Alprazolam | Draft | Oral | Tablet, Extended Release | 21434 | 11/2007 |
| Alprazolam Revised |
Draft | Oral | Tablet | 18276 | 9/2008 |
| Ambrisentan | Draft | Oral | Tablet | 22081 | 8/2009 |
| Aminosalicylic Acid | Draft | Oral | Granules, Delayed Release | 74346 | 7/2008 |
| Amlodipine Besylate | Final | Oral | Tablet | 19787 | 5/2008 |
| Amlodipine Besylate; Atorvastatin Calcium | Draft | Oral | Tablet | 21540 | 5/2009 |
| Amlodipine Besylate; Benazepril HCl | Final | Oral | Tablet | 20364 | 5/2008 |
| Amlodipine Besylate; Olmesartan Medoxomil | Draft | Oral | Tablet | 22100 | 10/2008 |
| Amlodipine Besylate; Valsartan | Draft | Oral | Tablet | 21990 | 8/2008 |
| Amoxicillin; Clavulanate Potassium | Draft | Oral | Tablet, Chewable | 50597 | 1/2008 |
| Amoxicillin; Clavulanate Potassium | Draft | Oral | Tablet, Chewable | 50726 | 1/2008 |
| Amoxicillin; Clavulanate Potassium | Final | Oral | Suspension | 50755 50725 |
5/2008 |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate | Draft | Oral | Tablet | 11522 | 12/2008 |
| Amprenavir | Draft | Oral | Capsule | 21007 | 8/2008 |
| Anagrelide HCl | Final | Oral | Capsule | 76468 | 5/2008 |
| Anastrozole | Final | Oral | Tablet | 20541 | 5/2008 |
| Aprepitant | Final | Oral | Capsule | 21549 | 5/2008 |
| Aripiprazole | Draft | Oral | Tablet | 21436 | 11/2007 |
| Armodafinil | Draft | Oral | Tablet | 21875 | 1/2008 |
| Atazanavir Sulfate | Final | Oral | Capsule | 21567 | 5/2008 |
| Atomoxetine HCl | Final | Oral | Capsule | 21411 | 5/2008 |
| Atorvastatin Calcium | Final | Oral | Tablet | 20702 | 5/2008 |
| Atovaquone | Draft | Oral | Tablet | 20259 | 11/2007 |
| Atovaquone; Proguanil | Draft | Oral | Tablet | 21078 | 7/2008 |
| Azacitidine Revised |
Draft | Oral | Injection | 50794 | 7/2009 |
| Azithromycin | Draft | Oral | Suspension | 50710 | 12/2008 |
| Azithromycin | Draft | Oral | Suspension, Extended Release | 50797 | 7/2008 |
| Azithromycin | Draft | Oral | Tablet | 50730 50711 50784 |
1/2008 |
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