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LEVOTHYROXINE

 
 
Content specific to this active ingredient…

Drug Information
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Type 2 master files on file at the FDA

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For prescription drugs containing this active ingredient

Exclusivity
Patent and market exclusivity data

Federal Register
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FDA Approved Labelling
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Research Links
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Title 21 Code of Federal Regulations
FDA regulations for this API

   

 


 

FDA Approval Activities for this Drug…

Levo-T (levothyroxine sodium USP), Alara Pharmaceutical 21-342/S2 8/21/03 8/28/03 8/28/03 Levo-T (levothyroxine sodium USP), 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg., Mova Pharmaceutical 21-342 3/1/02 6/19/02 5/24/02 6/19/02 Levo-T Indications: Hypothyroidism and supression of thyroid-stimulating hormone. Levolet (levothyroxine sodium) Vintage 21-137 Levothyroxine Sodium 0.025, 0.05, 0.075, 0.088, 0.1, 0.112, 0.125, 0.15, 0.175, 0.2 & 0., Mylan 76-187 6/5/02 7/8/03 7/8/03 Levoxyl (levothyroxine sodium) Jones Pharma 21-301/S6 7/23/03 8/6/03 Levoxyl (levothyroxine sodium) Jones Pharma 21-301/S2 7/17/02 7/24/02 Levoxyl (levothyroxine sodium) 25, 50, 88, 100, 125, 137, 150, 175 200 and 300 mcg strengths Jones Pharma 21-301 Novothyrox (levothyroxine sodium USP), 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg., Genpharm, 21-292 Synthroid (levothyroxine sodium) 25, 50, 75, 88, 100, 112, 125, 137, 150, 175, 200, and 300 mcg, Abbott 21-402 Thyro-Tabs(r) (levothyroxine sodium) 25, 50, 75, 88, 100, 112, 125, 150, 175, 200, and 300 mcg strengths, Lloyd 21-116 Unithroid (levothyroxine sodium) USP,Rx Jerome Stevens 21-210 8/21/00 8/22/00 8/22/00 1/4/01 Unithroid Indication: Hypothyroidism and suppression of thyroid stimulation hormone. LEVOTHYROXINE SODIUM 0.02 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.0 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.07 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.08 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.11 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.12 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.13 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.1 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0.17 SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0. SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0. SYNTHROID Abbott | 021402 LEVOTHYROXINE SODIUM 0. SYNTHROID Abbott | 021342 LEVOTHYROXINE SODIUM 0.02 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.0 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.07 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.08 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.11 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.12 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.1 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0.17 LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0. LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0. LEVO-T ALARA | 021342 LEVOTHYROXINE SODIUM 0. LEVO-T ALARA | 021292 LEVOTHYROXINE SODIUM 0.02 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.0 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.07 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.08 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.11 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.12 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.13 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.1 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0.17 NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0. NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0. NOVOTHYROX Genpharm | 021292 LEVOTHYROXINE SODIUM 0. NOVOTHYROX Genpharm | 021301 LEVOTHYROXINE SODIUM 0.02 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.0 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.07 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.08 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.11 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.12 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.13 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.1 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0.17 LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0. LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0. LEVOXYL JONES | 021301 LEVOTHYROXINE SODIUM 0. LEVOXYL JONES | 021116 LEVOTHYROXINE SODIUM 0.02 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.0 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.07 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.08 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.11 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.12 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.1 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0.17 THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0. THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0. THYRO-TABS LLOYD | 021116 LEVOTHYROXINE SODIUM 0. THYRO-TABS LLOYD | 076187 LEVOTHYROXINE SODIUM 0.02 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.0 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.07 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.08 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.11 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.12 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.1 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0.17 LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0. LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0. LEVOTHYROXINE SODIUM Mylan | 076187 LEVOTHYROXINE SODIUM 0. LEVOTHYROXINE SODIUM Mylan | 021210 LEVOTHYROXINE SODIUM 0.02 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.0 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.07 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.08 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.11 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.12 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.1 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0.17 UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0. UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0. UNITHROID STEVENS J | 021210 LEVOTHYROXINE SODIUM 0. UNITHROID STEVENS J | 021137 LEVOTHYROXINE SODIUM 0.02 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.0 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.07 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.08 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.11 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.12 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.13 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.1 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0.17 LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0. LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0. LEVOLET Vintage | 021137 LEVOTHYROXINE SODIUM 0. LEVOLET Vintage Levo-T (levothyroxine sodium) Alara Pharmaceutical Corporation Levo-T (levothyroxine sodium tablets, Alara Pharmaceuticals Levothyroxine Sodium Tablets, Mylan Pharmaceuticals, Inc. Unithroid (levothyroxine sodium tablets, Jerome Stevens Pharmaceuticals | Thyro-Tabs (levothyroxine sodium USP) Tablets, Lloyd, Inc., Control Supplement | Unithroid (levothyroxine sodium) Tablets, Jerome Stevens Pharma, Comparative Efficacy Claim | Levoxyl (levothyroxine sodium) Tablets, King Pharma, Labeling Revision | Thyro-Tabs (levothyroxine sodium) Tablets, Lloyd Inc., Labeling Revision | Tirosint (levothyroxine sodium capsules), Institute Biochimique, Approval | Levothyroxine Sodium Tablets, Mylan Pharma, New Strength | Tirosint (levothyroxine sodium) Capsules, Institut Biochimique, Approval | Tirosint (levothyroxine sodium) Capsules, Institut Biochimique, Labeling Revision | Unithroid (levothyroxine sodium) Tablets, Jerome Stevens Pharma, Formulation Revision | Synthroid (levothyroxine sodium) Tablets, Abbott Labs, Labeling Revision | Levo-T (levothyroxine sodium) Tablets, Alara Pharmaceutical Corp., Labeling Revision | Levoxyl (levothyroxine sodium) Tablets, King Pharmaceuticals, Inc., Labeling Revision | Synthroid (levothyroxine sodium) Tablets, Abbott Laboratories, Labeling Revision | Novothyrox (levothyroxine sodium) Tablets, Merck KGaA, Labeling Revision | Levo-T (levothyroxine sodium) Tablets, ALARA Pharmaceutical Corp., Control Supplement

^ FDA's latest approval appears at the bottom of this list. ^


 

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