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U.S. Department of Health and Human Services

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Bioequivalence Recommendations for Specific Products: Active Ingredients starting with 'L'

 

 

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
Labetalol HCl (PDF - 17KB) RevisedDraftOralTablet751134/2010
 Lacosamide (PDF - 47KB) Draft OralTablet222536/2012
Lamivudine (PDF - 39KB)DraftOralTablet2100311/2007
Lamivudine (PDF - 43KB)FinalOralTablet205645/2008
Lamivudine; Zidovudine (PDF - 41KB)FinalOralTablet208575/2008
Lamotrigine (PDF - 40KB)
Revised
DraftOralTablet, Extended Release221158/2010
Lamotrigine (PDF - 21KB)FinalOralTablet, Chewable207645/2008
Lamotrigine (PDF - 21KB)FinalOralTablet202415/2008
Lansoprazole (PDF - 37KB)RevisedFinalOralCapsule, Delayed Release204067/2014
Lansoprazole (PDF - 16KB)
Revised
DraftOralTablet, Delayed-Release, Orally Disintegrating214287/2009
Lanthanum Carbonate (PDF - 45KB)RevisedDraftOralTablets, Chewable2146811/2013
Lapatinib Ditosylate (PDF - 42KB)
Revised
DraftOralTablet220597/2010
Latanoprost (PDF - 14KB)DraftOphthalmicSolution205979/2008
Leflunomide (PDF - 18KB)DraftOralTablet209058/2007
Lenalidomide (PDF - 21KB)RevisedDraftOralCapsule2188011/2013
Leuprolide Acetate (PDF - 44KB) RevisedDraftInjectableInjection

19732 

20011 

20263 

2/2014
Leuprolide Acetate (PDF - 40KB) RevisedDraftInjectableInjection

20517 

20708 

2/2014
Letrozole (PDF - 17KB)DraftOralTablet207267/2008
Leucovorin Calcium (PDF - 16KB)DraftOralTablet

72733

72734

72735

72736 

7/2008
Leuprolide Acetate (PDF - 15KB)DraftImplantationImplant210887/2008
Levetiracetam (PDF - 30KB)DraftOralTablet, Extended Release222852/2010
Levetiracetam (PDF - 38KB)FinalOralTablet2103510/2011
Levocetirizine Dihydrochloride (PDF - 16KB)DraftOralTablet2206410/2008
Levofloxacin (PDF - 39KB) RevisedDraftOralTablet206348/2010
Levonorgestrel (PDF - 24KB) RevisedDraftOralTablet

21998

21045

78665

78666

2/2011
Lidocaine (PDF - 147KB)RevisedDraftTopicalPatch206127/2014
Linagliptin (PDF - 17KB)DraftOralTablet2012809/2012
Linagliptin/Metformin HCl (PDF - 25KB)DraftOralTablet2012814/2014
Linezolid (PDF - 35KB)FinalOralSuspension2113210/2011
Linezolid (PDF - 38KB) RevisedDraftOralTablet211308/2010
Liothyronine Sodium (PDF - 48KB)RevisedDraftOralTablet1037912/2012
Lisdexamfetamine Dimesylate (PDF - 16KB)DraftOralCapsule219779/2008
Lisinopril (PDF - 18KB)DraftOralTablet197771/2008
Lithium Carbonate (PDF - 17KB)DraftOralTablet, Extended Release766912/2010
Lithium Carbonate (PDF - 17KB)DraftOralTablet, Extended Release180272/2010
Lithium Carbonate (PDF - 16KB)DraftOralTablet185582/2010
Lithium Carbonate (PDF - 15KB)DraftOralCapsule178127/2008
Lopinavir; Ritonavir (PDF - 21KB)RevisedDraftOralCapsule212269/2012
Lopinavir; Ritonavir (PDF - 18KB)RevisedDraftOralTablet219069/2012
Loratadine (PDF - 22KB)DraftOralCapsule0219524/2013
Loratadine (PDF - 16KB)DraftOralTablet, Chewable218913/2009
Loratadine (PDF - 38KB)DraftOralTablet196587/2008
Loratadine (PDF - 51KB)FinalOralTablet, Orally Disintegrating207045/2008
Loratadine; Pseudoephedrine Sulfate (PDF - 39KB)DraftOralTablet, Extended Release196708/2010
Lorazepam (PDF - 27KB)DraftOralTablet177942/2010
Losartan Potassium (PDF - 60KB)FinalOralTablet203865/2008
Loteprednol Etabonate; Tobramycin (PDF - 70KB)Revised DraftOphthalmicSuspension508046/2012
Loteprednol Etabonate (PDF - 58KB)RevisedDraftOphthalmicDrops, suspension

20583

4/2013
Lovastatin; Niacin (PDF - 22KB)
Revised
DraftOralTablet, Extended Release2124912/2008
Lubiprostone (PDF - 230KB)DraftOralCapsule219088/2010