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Drugs
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Individual Product Bioequivalence Recommendations: Active Ingredients Starting with 'M'
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 |
|---|---|---|---|---|---|
| Mebendazole | Draft | Oral | Tablet, Chewable | 73580 | 2/2009 |
| Meclizine HCl (PDF - 16 KB) | Draft | Oral | Tablet | 10721 | 12/2009 |
| Mefenamic Acid | Draft | Oral | Capsule | 15034 | 2/2010 |
| Mefloquine HCl | Final | Oral | Tablet | 76175 | 5/2008 |
| Megestrol Acetate | Draft | Oral | Suspension | 20264 | 2/2010 |
| Megestrol Acetate | Draft | Oral | Suspension | 21778 | 2/2010 |
| Meloxicam | Final | Oral | Suspension | 21530 | 5/2008 |
| Meloxicam | Final | Oral | Tablet | 20938 | 5/2008 |
| Melphalan Revised |
Draft | Oral | Tablet | 14691 | 7/2009 |
| Memantine HCl Revised |
Draft | Oral | Tablet | 21487 | 3/2010 |
| Meprobamate | Draft | Oral | Tablet | 3/2009 | |
| Mercaptopurine revised |
Final | Oral | Tablet | 09053 | 12/2009 |
| Mesalamine | Draft | Rectal | Enema | 19618 | 1/2008 |
| Mesalamine | Draft | Rectal | Suppository | 21252 | 5/2007 |
| Metaxalone | Draft | Oral | Tablet | 13217 | 5/2007 |
| Metformin HCl Revised | Draft | Oral | Tablet, Extended Release | 21574 | 2/2010 |
|
Revised |
Draft | Oral | Tablet, Extended Release | 21748 | 2/2010 |
| Metformin HCl | Draft | Oral | Tablet | 20357 | 7/2008 |
| Metformin HCl | Final | Oral | Tablet, Extended Release | 21202 | 5/2008 |
| Metformin HCl; Pioglitazone | Final | Oral | Tablet | 21842 | 5/2008 |
| Metformin HCl; Repaglinide | Draft | Oral | Tablet | 22386 | 10/2009 |
| Metformin HCl; Sitagliptin Phosphate | Draft | Oral | Tablet | 22044 | 9/2008 |
| Methadone HCl | Draft | Oral | Tablet | 7/2008 | |
| Methimazole | Draft | Oral | Tablet | 40350 | 2/2010 |
| Methotrexate Sodium | Draft | Oral | Tablet | 08085 | 4/2009 |
| Methotrexate Sodium | Draft | Oral | Tablet | 40385 | 4/2009 |
| Methylphenidate HCl | Draft | Oral | Tablet | 10187 | 2/2010 |
| Methylphenidate HCl (PDF - 17 KB) | Draft | Oral | Tablet, Chewable | 21475 | 12/2009 |
| Methylprednisolone | Draft | Oral | Tablet | 11153 | 2/2010 |
| Methylprednisolone Acetate Revised |
Draft | Injection | Suspension | 11757 | 5/2009 |
| Metoclopramide HCl | Draft | Oral | Tablet | 17854 | 5/2009 |
| Metoprolol Succinate Revised |
Draft | Oral | Tablet, Extended Release | 19962 | 4/2008 |
| Miconazole Nitrate | Draft | Vaginal | Cream | 17450 | 10/2009 |
| Miconazole Nitrate | Draft | Vaginal | Cream | 20827 | 10/2009 |
| Miconazole Nitrate | Draft | Vaginal | Suppository | 18520 | 10/2009 |
| Miconazole Nitrate | Draft | Vaginal | Suppository | 18888 | 10/2009 |
| Midodrine HCl | Draft | Oral | Tablet | 19815 | 8/2008 |
| Miglustat | Final | Oral | Capsule | 21348 | 5/2008 |
| Minocycline HCl | Draft | Oral | Capsule | 7/2008 | |
| Minocycline HCl | Draft | Oral | Tablet, Extended Release | 50808 | 11/2007 |
| Minoxidil Revised |
Draft | Oral | Tablet | 71344 71345 |
7/2008 |
| Mirtazapine | Final | Oral | Tablet, Orally Disintegrating | 21208 | 5/2008 |
| Misoprostol | Draft | Oral | Tablet | 19268 | 2/2010 |
| Modafinil | Final | Oral | Tablet | 20717 | 5/2008 |
| Moexipril HCl | Final | Oral | Tablet | 20312 | 5/2008 |
| Montelukast | Draft | Oral | Granule | 21409 | 7/2008 |
| Montelukast Sodium | Draft | Oral | Tablet | 20829 | 7/2008 |
| Montelukast Sodium Revised |
Draft | Oral | Tablet, Chewable | 20830 | 7/2008 |
| Morphine Sulfate | Draft | Oral | Tablet | 22207 | 2/2010 |
| Morphine Sulfate Revised |
Draft | Oral | Capsule, Extended Release | 20616 | 9/2008 |
| Moxifloxacin HCl | Draft | Oral | Tablet | 21085 | 7/2008 |
| Mycophenolate Mofetil | Draft | Oral | Capsule | 50722 | 8/2007 |
| Mycophenolate Mofetil HCl | Draft | Oral | Tablet | 50723 | 8/2007 |
| Mycophenolic Acid | Draft | Oral | Tablet, Delayed Release | 50791 | 12/2008 |
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