Drugs

Product-Specific Recommendations for Generic Drug Development: 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)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date
Recommended
 Malathion (PDF - 166KB) Draft Topical Lotion186136/2012
Maraviroc (PDF - 36KB)DraftOralTablet2212811/2010
Mebendazole (PDF - 83KB)DraftOralTablet, Chewable735802/2009
Meclizine HCl(PDF - 16KB) DraftOralTablet, Chewable107214/2010
Meclizine HCl (PDF - 16KB)DraftOralTablet1072112/2009

 Medroxyprogesterone Acetate (PDF - 24KB) 

DraftIntramuscularSuspension

012541

6/2013

 Medroxyprogesterone Acetate (PDF - 24KB

Draft IntramuscularSuspension0202466/2013
Mefenamic Acid (PDF - 26KB)DraftOralCapsule150342/2010
Mefloquine HCl (PDF - 42KB)FinalOralTablet761755/2008
Megestrol Acetate (PDF - 26KB)DraftOralSuspension202642/2010
Megestrol Acetate (PDF - 27KB)DraftOralSuspension217782/2010
Meloxicam (PDF - 49KB)FinalOralSuspension215305/2008
Meloxicam (PDF - 49KB)FinalOralTablet209385/2008
Melphalan (PDF - 15KB)
Revised
DraftOralTablet146917/2009
Memantine HCl (PDF - 17KB)
Revised
DraftOralTablet2148712/2014
Memantine HCl (PDF - 27KB) RevisedDraftOralCapsule, Extended Release2252512/2014

Menthol; Methyl Salicylate (PDF -158KB)

DraftTopicalPatch220297/2014
Meprobamate (PDF - 30KB)FinalOralTablet

83304

83308

10/2011
Mercaptopurine (PDF - 22KB)
revised
FinalOralTablet0405284/2011
Mesalamine (PDF - 44KB)DraftOralCapsule, Delayed Release2044124/2014
Mesalamine (PDF - 66KB)RevisedDraftOralCapsule, Extended Release200497/2014
Mesalamine (PDF - 65KB)RevisedDraft OralCapsule, Extended Release223017/2014
Mesalamine (PDF - 67KB)Draft OralTablet, Delayed Release196519/2012
Mesalamine (PDF - 67KB)Draft OralTablet, Delayed Release218309/2012
Mesalamine (PDF - 66KB)Draft OralTablet, Delayed Release220009/2012
Mesalamine (PDF - 24KB)DraftRectalEnema196181/2008
Mesalamine (PDF - 35KB)RevisedDraftRectalSuppository212523/2013

Mesna (PDF - 23KB)

DraftOralTablet

20855

11/2013
Mestranol; Norethindrone (PDF - 16KB)DraftOralTablet166594/2010
Metaxalone (PDF - 35KB)DraftOralTablet132175/2007
Metformin HCl (PDF - 19KB) RevisedDraftOralTablet, Extended Release215742/2010

Metformin HCl (PDF - 19KB)

Revised

DraftOralTablet, Extended Release217482/2010
Metformin HCl (PDF - 16KB)DraftOralTablet203577/2008
Metformin HCl (PDF - 64KB)FinalOralTablet, Extended Release212025/2008
Metformin HCl; Pioglitazone HCl (PDF - 58KB) FinalOralTablet218425/2008
Metformin HCl; Pioglitazone HCl (PDF - 19KB)DraftOralTablet, Extended Release220243/2010
Metformin HCl; Repaglinide (PDF - 30KB)DraftOralTablet2238612/2010
Metformin HCl; Saxagliptin (PDF - 27KB)DraftOralTablet, Extended Release2006783/2012

Metformin HCl; Sitagliptin Phosphate (PDF - 26KB)

DraftOralTablet, Extended Release2022707/2014
Metformin HCl; Sitagliptin Phosphate (PDF - 16KB)DraftOralTablet220449/2008
Methadone HCl (PDF - 15KB)DraftOralTablet

06134

17058

7/2008

Methenamine Hippurate (PDF - 23KB)

Draft OralTablet1768111/2013
Methimazole (PDF - 25KB)DraftOralTablet403502/2010
Methocarbamol (PDF - 22KB)DraftOralTablet1101111/2013
Methotrexate Sodium (PDF - 25KB)FinalOralTablet0808510/2011
Methotrexate Sodium (PDF - 26KB)FinalOralTablet4038510/2011
Methoxsalen (PDF - 25KB)DraftOralCapsule090484/2010
Methoxsalen (PDF - 24KB) DraftOralCapsule196004/2010

Methylphenidate (PDF - 266KB)

DraftTransdermalFilm, Extended Release215147/2010
Methylphenidate HCl (PDF - 33KB)Draft OralSuspension,Extended Release20210012/2014
Methylphenidate HCl (PDF - 81KB)Draft OralCapsule, Extended Release212599/2012
 

Methylphenidate HCl (PDF - 80KB)

Draft OralTablet, Extended Release2112111/2014
Methylphenidate HCl (PDF - 50KB) Revised DraftOralCapsules, Extended Release212843/2015
Methylphenidate HCl (PDF - 21KB)DraftOralTablet101872/2010
Methylphenidate HCl (PDF - 17KB)DraftOralTablet, Chewable2147512/2009
Methylphenidate HCl (PDF - 33KB)Draft OralSuspension,Extended Release20210012/2014
Methylprednisolone (PDF - 17KB)DraftOralTablet111532/2010
Methylprednisolone Acetate (PDF - 29KB)   RevisedFinalInjectionSuspension1175712/2014

 Methyltestosterone  (PDF - 22KB)

DraftOralCapsule0839766/2013
Metoclopramide HCl (PDF - 35KB)DraftOralTablet, Orally Disintegrating222469/2010
Metoclopramide HCl (PDF - 29KB)FinalOralTablet1785410/2011

Metolazone (PDF - 35KB)

DraftOralTablet1738611/2010
Metoprolol Succinate (PDF - 29KB)
Revised
DraftOralTablet, Extended Release199622/2014
Metoprolol tartrate (PDF - 22KB)DraftOralTablet07670412/2014
Metronidazole (PDF - 112KB)DraftVaginalGel

20208

21806
4/2013
Metronidazole (PDF - 33KB) DraftOralTablet126239/2010
Metronidazole (PDF - 112KB)DraftTopicalGel

20208

21806
3/2013
Metronidazole (PDF - 84KB)DraftTopicalCream205313/2010
Metronidazole (PDF - 88KB)DraftTopicalCream207433/2010
Metronidazole (PDF - 48KB)DraftTopicalGel197373/2010
Metronidazole (PDF - 84KB)DraftTopicalGel217893/2010
Metronidazole (PDF - 48KB)DraftTopicalLotion209013/2010
Miconazole (PDF - 63KB)DraftBuccalTablet224044/2013
Miconazole Nitrate (PDF - 78KB)DraftVaginalCream1745010/2009
Miconazole Nitrate (PDF - 76KB)DraftVaginalCream2082710/2009
Miconazole Nitrate (PDF - 80KB)DraftVaginalSuppository1852010/2009
Miconazole Nitrate (PDF - 77KB)DraftVaginalSuppository1888810/2009
Midodrine HCl (PDF - 20KB)DraftOralTablet765778/2008
Mifepristone (PDF - 28KB)DraftOralTablet206876/2011
Miglustat (PDF - 45KB)FinalOralCapsule213485/2008
Milnacipran HCl (PDF - 38KB) RevisedDraftOralTablet222569/2011

 Minocycline HCl (PDF - 113KB) 

DraftDentalPowder, Extended Release507813/2015
Minocycline HCl (PDF - 24KB)DraftOralCapsule, Extended Release2019224/2013
Minocycline HCl (PDF - 29KB)DraftOralTablet651315/2010
Minocycline HCl (PDF - 15KB)DraftOralCapsule

63009

63011

7/2008
Minocycline HCl (PDF - 18KB) RevisedDraftOralTablet, Extended Release508086/2013
Minoxidil (PDF - 38KB) RevisedDraftTopicalAerosol, Foam218122/2011
Minoxidil (PDF - 29KB)DraftTopicalSolution195015/2010
Minoxidil (PDF - 29KB)DraftTopicalSolution208345/2010
Minoxidil (PDF - 15KB)
Revised
DraftOralTablet71344
71345
7/2008

 Mirabegron (PDF - 23KB)

DraftOralTablet, Extended Release2026116/2013

Mirtazapine (PDF - 49KB) Revised

DraftOralTablet204153/2015
Mirtazapine (PDF - 45KB)FinalOralTablet, Orally Disintegrating212085/2008
Misoprostol (PDF - 25KB)DraftOralTablet192682/2010
Mitotane (PDF -21KB)DraftOralTablet0168854/2013
Modafinil (PDF - 48KB)FinalOralTablet207175/2008
Moexipril HCl (PDF - 47KB)FinalOralTablet203125/2008
Molindone HCl (PDF - 17KB)DraftOralTablet171113/2010
Montelukast (PDF - 16KB)DraftOralGranule214097/2008
Montelukast Sodium (PDF - 21KB)DraftOralTablet208297/2008
Montelukast Sodium (PDF - 19KB)
Revised
DraftOralTablet, Chewable208307/2008
 Morphine Sulfate; Naltrexone HCl (PDF - 102KB) Draft OralCapsule, Extended Release223216/2012

Morphine Sulfate (PDF - 42KB)

DraftOralTablet, Extended Release1951612/2010
Morphine Sulfate (PDF - 41KB)DraftOralCapsule, Extended Release2126011/2010
Morphine Sulfate (PDF - 17KB)DraftOralTablet222072/2010
Morphine Sulfate (PDF - 23KB)
Revised
DraftOralCapsule, Extended Release206162/2014
Moxifloxacin HCl (PDF - 16KB)DraftOralTablet210857/2008
Mupirocin (PDF - 52KB)DraftTopicalOintment50591 6/2010
Mupirocin Calcium (PDF - 226KB) RevisedDraftTopicalCream5074610/2011
Mupirocin Calcium (PDF - 37KB)DraftNasalOintment507036/2010
Mycophenolate Mofetil (PDF - 14KB)n RevisedDraftOralSuspension507592/2014
Mycophenolate Mofetil (PDF - 18KB) RevisedDraftOralCapsule507222/2014
Mycophenolate Mofetil HCl (PDF - 18KB) RevisedDraftOralTablet507232/2014
Mycophenolic Acid (PDF - 15KB) RevisedDraftOralTablet, Delayed Release507912/2014

 

Page Last Updated: 06/15/2015
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