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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 'M'

 

 

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
 Malathion (PDF - 166KB)  Draft  Topical  Lotion 18613 6/2012
Maraviroc (PDF - 36KB) Draft Oral Tablet 22128 11/2010
Mebendazole (PDF - 83KB) Draft Oral Tablet, Chewable 73580 2/2009
Meclizine HCl(PDF - 16KB) Draft Oral Tablet, Chewable 10721 4/2010
Meclizine HCl (PDF - 16KB) Draft Oral Tablet 10721 12/2009

 Medroxyprogesterone Acetate (PDF - 24KB) 

Draft Intramuscular Suspension

012541

6/2013

 Medroxyprogesterone Acetate (PDF - 24KB

Draft  Intramuscular Suspension 020246 6/2013
Mefenamic Acid (PDF - 26KB) Draft Oral Capsule 15034 2/2010
Mefloquine HCl (PDF - 42KB) Final Oral Tablet 76175 5/2008
Megestrol Acetate (PDF - 26KB) Draft Oral Suspension 20264 2/2010
Megestrol Acetate (PDF - 27KB) Draft Oral Suspension 21778 2/2010
Meloxicam (PDF - 49KB) Final Oral Suspension 21530 5/2008
Meloxicam (PDF - 49KB) Final Oral Tablet 20938 5/2008
Melphalan (PDF - 15KB)
Revised
Draft Oral Tablet 14691 7/2009
Memantine HCl (PDF - 17KB)
Revised
Draft Oral Tablet 21487 3/2010
Memantine HCl (PDF - 27KB) Draft Oral Capsule, Extended Release 22525 3/2012
Meprobamate (PDF - 30KB) Final Oral Tablet

83304

83308

10/2011
Mercaptopurine (PDF - 22KB)
revised
Final Oral Tablet 09053 4/2011
Mesalamine (PDF - 66KB) Draft Oral Capsule, Extended Release 20049 9/2012
Mesalamine (PDF - 65KB) Draft  Oral Capsule, Extended Release 22301 9/2012
Mesalamine (PDF - 67KB) Draft  Oral Tablet, Delayed Release 19651 9/2012
Mesalamine (PDF - 67KB) Draft  Oral Tablet, Delayed Release 21830 9/2012
Mesalamine (PDF - 66KB) Draft  Oral Tablet, Delayed Release 22000 9/2012
Mesalamine (PDF - 24KB) Draft Rectal Enema 19618 1/2008
Mesalamine (PDF - 35KB)Revised Draft Rectal Suppository 21252 3/2013

Mesna (PDF - 23KB)

Draft Oral Tablet

20855

11/2013
Mestranol; Norethindrone (PDF - 16KB) Draft Oral Tablet 16659 4/2010
Metaxalone (PDF - 35KB) Draft Oral Tablet 13217 5/2007
Metformin HCl (PDF - 19KB) Revised Draft Oral Tablet, Extended Release 21574 2/2010

Metformin HCl (PDF - 19KB)

Revised

Draft Oral Tablet, Extended Release 21748 2/2010
Metformin HCl (PDF - 16KB) Draft Oral Tablet 20357 7/2008
Metformin HCl (PDF - 64KB) Final Oral Tablet, Extended Release 21202 5/2008
Metformin HCl; Pioglitazone HCl (PDF - 58KB) Final Oral Tablet 21842 5/2008
Metformin HCl; Pioglitazone HCl (PDF - 19KB) Draft Oral Tablet, Extended Release 22024 3/2010
Metformin HCl; Repaglinide (PDF - 30KB) Draft Oral Tablet 22386 12/2010
Metformin HCl; Saxagliptin (PDF - 27KB) Draft Oral Tablet, Extended Release 200678 3/2012
Metformin HCl; Sitagliptin Phosphate (PDF - 16KB) Draft Oral Tablet 22044 9/2008
Methadone HCl (PDF - 15KB) Draft Oral Tablet

06134

17058

7/2008

Methenamine Hippurate (PDF - 23KB)

Draft  Oral Tablet 17681 11/2013
Methimazole (PDF - 25KB) Draft Oral Tablet 40350 2/2010
Methocarbamol (PDF - 22KB) Draft Oral Tablet 11011 11/2013
Methotrexate Sodium (PDF - 25KB) Final Oral Tablet 08085 10/2011
Methotrexate Sodium (PDF - 26KB) Final Oral Tablet 40385 10/2011
Methoxsalen (PDF - 25KB) Draft Oral Capsule 09048 4/2010
Methoxsalen (PDF - 24KB) Draft Oral Capsule 19600 4/2010

Methylphenidate (PDF - 266KB)

Draft Transdermal Film, Extended Release 21514 7/2010
Methylphenidate HCl (PDF - 81KB) Draft  Oral Capsule, Extended Release 21259 9/2012
 

Methylphenidate HCl (PDF - 80KB)

Draft  Oral Tablet, Extended Release 21121 9/2012
Methylphenidate HCl (PDF - 50KB)  Draft Oral Capsules, Extended Release 21284 11/2011
Methylphenidate HCl (PDF - 21KB) Draft Oral Tablet 10187 2/2010
Methylphenidate HCl (PDF - 17KB) Draft Oral Tablet, Chewable 21475 12/2009
Methylprednisolone (PDF - 17KB) Draft Oral Tablet 11153 2/2010
Methylprednisolone Acetate (PDF - 29KB)
Final Injection Suspension 11757 10/2011

 Methyltestosterone  (PDF - 22KB)

Draft Oral Capsule 083976 6/2013
Metoclopramide HCl (PDF - 35KB) Draft Oral Tablet, Orally Disintegrating 22246 9/2010
Metoclopramide HCl (PDF - 29KB) Final Oral Tablet 17854 10/2011

Metolazone (PDF - 35KB)

Draft Oral Tablet 17386 11/2010
Metoprolol Succinate (PDF - 29KB)
Revised
Draft Oral Tablet, Extended Release 19962 2/2014
Metronidazole (PDF - 112KB) Draft Vaginal Gel

20208

21806
4/2013
Metronidazole (PDF - 33KB)  Draft Oral Tablet 12623 9/2010
Metronidazole (PDF - 112KB) Draft Topical Gel

20208

21806
3/2013
Metronidazole (PDF - 84KB) Draft Topical Cream 20531 3/2010
Metronidazole (PDF - 88KB) Draft Topical Cream 20743 3/2010
Metronidazole (PDF - 48KB) Draft Topical Gel 19737 3/2010
Metronidazole (PDF - 84KB) Draft Topical Gel 21789 3/2010
Metronidazole (PDF - 48KB) Draft Topical Lotion 20901 3/2010
Miconazole (PDF - 63KB) Draft Buccal Tablet 22404 4/2013
Miconazole Nitrate (PDF - 78KB) Draft Vaginal Cream 17450 10/2009
Miconazole Nitrate (PDF - 76KB) Draft Vaginal Cream 20827 10/2009
Miconazole Nitrate (PDF - 80KB) Draft Vaginal Suppository 18520 10/2009
Miconazole Nitrate (PDF - 77KB) Draft Vaginal Suppository 18888 10/2009
Midodrine HCl (PDF - 20KB) Draft Oral Tablet 76577 8/2008
Mifepristone (PDF - 28KB) Draft Oral Tablet 20687 6/2011
Miglustat (PDF - 45KB) Final Oral Capsule 21348 5/2008
Milnacipran HCl (PDF - 38KB) Revised Draft Oral Tablet 22256 9/2011
Minocycline HCl (PDF - 24KB) Draft Oral Capsule, Extended Release 201922 4/2013
Minocycline HCl (PDF - 29KB) Draft Oral Tablet 65131 5/2010
Minocycline HCl (PDF - 15KB) Draft Oral Capsule

63009

63011

7/2008
Minocycline HCl (PDF - 18KB) Revised Draft Oral Tablet, Extended Release 50808 6/2013
Minoxidil (PDF - 38KB) Revised Draft Topical Aerosol, Foam 21812 2/2011
Minoxidil (PDF - 29KB) Draft Topical Solution 19501 5/2010
Minoxidil (PDF - 29KB) Draft Topical Solution 20834 5/2010
Minoxidil (PDF - 15KB)
Revised
Draft Oral Tablet 71344
71345
7/2008

 Mirabegron (PDF - 23KB)

Draft Oral Tablet, Extended Release 202611 6/2013

Mirtazapine (PDF - 49KB)

Draft Oral Tablet 20415 12/2010
Mirtazapine (PDF - 45KB) Final Oral Tablet, Orally Disintegrating 21208 5/2008
Misoprostol (PDF - 25KB) Draft Oral Tablet 19268 2/2010
Mitotane (PDF -21KB) Draft Oral Tablet 016885 4/2013
Modafinil (PDF - 48KB) Final Oral Tablet 20717 5/2008
Moexipril HCl (PDF - 47KB) Final Oral Tablet 20312 5/2008
Molindone HCl (PDF - 17KB) Draft Oral Tablet 17111 3/2010
Montelukast (PDF - 16KB) Draft Oral Granule 21409 7/2008
Montelukast Sodium (PDF - 21KB) Draft Oral Tablet 20829 7/2008
Montelukast Sodium (PDF - 19KB)
Revised
Draft Oral Tablet, Chewable 20830 7/2008
 Morphine Sulfate; Naltrexone HCl (PDF - 102KB)  Draft  Oral Capsule, Extended Release 22321 6/2012

Morphine Sulfate (PDF - 42KB)

Draft Oral Tablet, Extended Release 19516 12/2010
Morphine Sulfate (PDF - 41KB) Draft Oral Capsule, Extended Release 21260 11/2010
Morphine Sulfate (PDF - 17KB) Draft Oral Tablet 22207 2/2010
Morphine Sulfate (PDF - 23KB)
Revised
Draft Oral Capsule, Extended Release 20616 2/2014
Moxifloxacin HCl (PDF - 16KB) Draft Oral Tablet 21085 7/2008
Mupirocin (PDF - 52KB) Draft Topical Ointment 50591  6/2010
Mupirocin Calcium (PDF - 226KB) Revised Draft Topical Cream 50746 10/2011
Mupirocin Calcium (PDF - 37KB) Draft Nasal Ointment 50703 6/2010
Mycophenolate Mofetil (PDF - 14KB)n Revised Draft Oral Suspension 50759 2/2014
Mycophenolate Mofetil (PDF - 18KB) Revised Draft Oral Capsule 50722 2/2014
Mycophenolate Mofetil HCl (PDF - 18KB) Revised Draft Oral Tablet 50723 2/2014
Mycophenolic Acid (PDF - 15KB) Revised Draft Oral Tablet, Delayed Release 50791 2/2014