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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 '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)		 Type Route of Administration Dosage Form RLD Application Number
(link to Orange Book)		 Date
Recommended
Labetalol HCl (PDF - 17KB) Revised Draft Oral Tablet 75113 4/2010
 Lacosamide (PDF - 47KB)  Draft  Oral Tablet 22253 6/2012
Lamivudine (PDF - 39KB) Draft Oral Tablet 21003 11/2007
Lamivudine (PDF - 43KB) Final Oral Tablet 20564 5/2008
Lamivudine; Zidovudine (PDF - 41KB) Final Oral Tablet 20857 5/2008
Lamotrigine (PDF - 40KB)
Revised		 Draft Oral Tablet, Extended Release 22115 8/2010
Lamotrigine (PDF - 21KB) Final Oral Tablet, Chewable 20764 5/2008
Lamotrigine (PDF - 21KB) Final Oral Tablet 20241 5/2008
Lansoprazole (PDF - 37KB) Final Oral Capsule, Delayed Release 20406 10/2011
Lansoprazole (PDF - 16KB)
Revised		 Draft Oral Tablet, Delayed-Release, Orally Disintegrating 21428 7/2009
Lanthanum Carbonate (PDF - 45KB) Draft Oral Tablets, Chewable 21468 8/2011
Lapatinib Ditosylate (PDF - 42KB)
Revised		 Draft Oral Tablet 22059 7/2010
Latanoprost (PDF - 14KB) Draft Ophthalmic Solution 20597 9/2008
Leflunomide (PDF - 18KB) Draft Oral Tablet 20905 8/2007
Lenalidomide (PDF - 21KB) Draft Oral Capsule 21880 11/2012
Leuprolide Acetate (PDF - 44KB) Draft Injectable Injection

19732 

20011 

20263 

 5/2010
Leuprolide Acetate (PDF - 40KB) Draft Injectable Injection

20517 

20708 

 5/2010
Letrozole (PDF - 17KB) Draft Oral Tablet 20726 7/2008
Leucovorin Calcium (PDF - 16KB) Draft Oral Tablet

72733

72734

72735

72736 

 7/2008
Leuprolide Acetate (PDF - 15KB) Draft Implantation Implant 21088 7/2008
Levetiracetam (PDF - 30KB) Draft Oral Tablet, Extended Release 22285 2/2010
Levetiracetam (PDF - 38KB) Final Oral Tablet 21035 10/2011
Levocetirizine Dihydrochloride (PDF - 16KB) Draft Oral Tablet 22064 10/2008
Levofloxacin (PDF - 39KB) Revised Draft Oral Tablet 20634 8/2010
Levonorgestrel (PDF - 24KB) Revised Draft Oral Tablet

21998

21045

78665

78666

 2/2011
Lidocaine (PDF - 147KB) Draft Topical Patch 20612 5/2007
Linagliptin (PDF - 17KB) Draft Oral Tablet 201280 9/2012
Linezolid (PDF - 35KB) Final Oral Suspension 21132 10/2011
Linezolid (PDF - 38KB) Revised Draft Oral Tablet 21130 8/2010
Liothyronine Sodium (PDF - 48KB)Revised Draft Oral Tablet 10379 12/2012
Lisdexamfetamine Dimesylate (PDF - 16KB) Draft Oral Capsule 21977 9/2008
Lisinopril (PDF - 18KB) Draft Oral Tablet 19777 1/2008
Lithium Carbonate (PDF - 17KB) Draft Oral Tablet, Extended Release 76691 2/2010
Lithium Carbonate (PDF - 17KB) Draft Oral Tablet, Extended Release 18027 2/2010
Lithium Carbonate (PDF - 16KB) Draft Oral Tablet 18558 2/2010
Lithium Carbonate (PDF - 15KB) Draft Oral Capsule 17812 7/2008
Lopinavir; Ritonavir (PDF - 21KB)Revised Draft Oral Capsule 21226 9/2012
Lopinavir; Ritonavir (PDF - 18KB)Revised Draft Oral Tablet 21906 9/2012
Loratadine (PDF - 16KB) Draft Oral Tablet, Chewable 21891 3/2009
Loratadine (PDF - 38KB) Draft Oral Tablet 19658 7/2008
Loratadine (PDF - 51KB) Final Oral Tablet, Orally Disintegrating 20704 5/2008
Loratadine; Pseudoephedrine Sulfate (PDF - 39KB) Draft Oral Tablet, Extended Release 19670 8/2010
Lorazepam (PDF - 27KB) Draft Oral Tablet 17794 2/2010
Losartan Potassium (PDF - 60KB) Final Oral Tablet 20386 5/2008
Loteprednol Etabonate; Tobramycin (PDF - 70KB)Revised  Draft Ophthalmic Suspension 50804 6/2012
Loteprednol Etabonate (PDF - 58KB)Revised Draft Ophthalmic Drops, suspension

20583

 4/2013
Lovastatin; Niacin (PDF - 22KB)
Revised		 Draft Oral Tablet, Extended Release 21249 12/2008
Lubiprostone (PDF - 230KB) Draft Oral Capsule 21908 8/2010

 

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