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FDA Approval Activities for this Drug…
Altocor (lovastatin) Extended-Release Tablets, Andrx, NDA 21-316/S6 9/24/03 9/30/03 9/30/03 | Altocor (lovastatin) Extended-Release Tablets, Andrx, NDA 21-316/S5 8/20/03 8/28/03 | Altocor (lovastatin) Extended-Release Tablets, Andrx, NDA 21-316/S1 9/11/02 9/18/02 9/12/02 | Altocor (lovastatin) Extended-Release Tablets, 10 mg, 20 mg, 40 mg, 60 mg, Aura , NDA 21-316 Lovastatin Tablets USP, 10mg, 20mg, & 40mg., Carlsbad Technology, ANDA 75-991 6/5/02 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., Genpharm ANDA 75-935 12/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., 7/18/01 Genpharm ANDA 75-935 7/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., Purepac Pharmaceutical Co. ANDA 75-828 12/17/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., Purepac Pharmaceutical Co. ANDA 75-828 12/19/00 3/5/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., Eon Labs Manufacturing, ANDA 75-636 12/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., 7/18/01 Eon Labs Manufacturing, ANDA 75-636 7/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg., 4/28/00 Eon Labs Manufacturing, ANDA 75-636 4/28/00 4/28/00 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg, 7/18/01 Teva USA ANDA 75-551 7/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg. Teva USA ANDA 75-551 12/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg. (Tentatively approved 9/30/99) Teva USA ANDA 75-551 9/30/99 10/1/99 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg, Mylan ANDA 75-451 12/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg, 7/18/01 Mylan ANDA 75-451 7/18/01 | Lovastatin Tablets USP, 10mg, 20mg, & 40mg. (Tentatively approved 6/7/99) Mylan ANDA 75-451 5/28/99 6/7/99 | Lovastatin Tablets USP, 10 mg, 20 mg, & 40 mg, 7/18/01 Geneva ANDA 75-300 7/18/01 | Lovastatin Tablets USP, 10 mg, 20 mg, & 40 mg, Geneva ANDA 75-300 12/17/01 | Lovastatin Tablets USP, 10 mg, 20 mg, & 40 mg. (Tentatively approved 6/30/99) Geneva ANDA 75-300 Mevacor (lovastatin) Tablets, Merck & Co., NDA 19-643/S-69 4/17/03 | Mevacor (lovastatin) Tablets, Merck & Co., NDA 19-643/S-71 9/20/02 9/24/02 9/23/02 | Mevacor (lovastatin) Tablets, Merck & Co., NDA 19-643/S-67 2/14/02 2/21/02 2/21/02 | Mevacor (lovastatin) Tablets, Merck Research NDA 19-643/S-62 & 64 4/26/01 8/17/01 | Mevacor (lovastatin) tablets, Merck Research NDA 19-643/S-055 3/11/99 5/17/00 | Mevacor Indication:Provides for a new indication for the use of Mevacor in the primary prevention of coronary heart disease in patients without symptomatic cardiovascular disease who have average to moderately elevated total-C and LDL-C and below average HDL-C. | Mevacor (lovastatin) tablets, Merck Research NDA 19-643/S-064 | LOVASTATIN Tablet, Extended Release; 10MG ALTOCOR Andrx | 021316 LOVASTATIN Tablet, Extended Release; 20MG ALTOCOR Andrx | 021316 LOVASTATIN Tablet, Extended Release; 40MG ALTOCOR Andrx | 021316 LOVASTATIN Tablet, Extended Release; 60MG ALTOCOR Andrx | 075991 LOVASTATIN Tablet; 10MG LOVASTATIN CARLSBAD | 075991 LOVASTATIN Tablet; 20MG LOVASTATIN CARLSBAD | 075991 LOVASTATIN Tablet; 40MG LOVASTATIN CARLSBAD | 075636 LOVASTATIN Tablet; 10MG LOVASTATIN Eon | 075636 LOVASTATIN Tablet; 20MG LOVASTATIN Eon | 075636 LOVASTATIN Tablet; 40MG LOVASTATIN Eon | 075300 LOVASTATIN Tablet; 10MG LOVASTATIN Geneva | 075300 LOVASTATIN Tablet; 20MG LOVASTATIN Geneva | 075300 LOVASTATIN Tablet; 40MG LOVASTATIN Geneva | 075935 LOVASTATIN Tablet; 10MG LOVASTATIN Genpharm | 075935 LOVASTATIN Tablet; 20MG LOVASTATIN Genpharm | 075935 LOVASTATIN Tablet; 40MG LOVASTATIN Genpharm | 019643 LOVASTATIN Tablet; 10MG MEVACOR MERCK | 019643 LOVASTATIN Tablet; 20MG MEVACOR MERCK | 019643 LOVASTATIN Tablet; 40MG MEVACOR MERCK | 075451 LOVASTATIN Tablet; 10MG LOVASTATIN Mylan | 075451 LOVASTATIN Tablet; 20MG LOVASTATIN Mylan | 075451 LOVASTATIN Tablet; 40MG LOVASTATIN Mylan | 075828 LOVASTATIN Tablet; 10MG LOVASTATIN Purepac | 075828 LOVASTATIN Tablet; 20MG LOVASTATIN Purepac | 075828 LOVASTATIN Tablet; 40MG LOVASTATIN Purepac | 075551 LOVASTATIN Tablet; 10MG LOVASTATIN Teva | 075551 LOVASTATIN Tablet; 20MG LOVASTATIN Teva | 075551 LOVASTATIN Tablet; 40MG LOVASTATIN Teva | 021249 LOVASTATIN; NIACIN Tablet, Extended Release; 20MG;1GM ADVICOR KOS | 021249 LOVASTATIN; NIACIN Tablet, Extended Release; 20MG;500MG ADVICOR KOS | 021249 LOVASTATIN; NIACIN Tablet, Extended Release; 20MG;750MG ADVICOR KOS Altoprev (lovastatin) Extended Release Tablets, Andrx Laboratories, Labeling Revision | Mevacor (lovastatin) Tablets, Merck & Co., Efficacy Supplement w/Clinical Data to Support | Mevacor (lovastatin) Tablets, Merck & Co., Labeling Revision | Mevacor (lovastatin) Tablets, Merck & Co., Labeling Revision | Lovastatin Tablets, Mutual Pharma, Approval | Advicor (niacin extended-release/lovastatin tablets), Kos Life Sci., Labeling Revision & Formulation Revision | Altoprev (lovastatin) Extended-Release Tablets, Andrx Labs, Labeling Revision | Advicor (niacin/lovastatin) Extended-Release Tablets, Kos, Labeling Revision | Mevacor (lovastatin) Tablets, Merck & Co., Labeling | Mevacor (lovastatin) Tablets, Merck & Co., Inc., Labeling Revision | Lovastatin Tablets, Lupin Ltd., Approval | Mevacor (lovastatin) Tablets, Merck & Co., Manufacturing Change or Addition | Advicor (niacin lovastatin) Extended Release Tablets, Abbott Labs, Labeling Revision | Mevacor (lovastatin) Tablets, Merck & Co., Inc., Control Supplement | Advicor (niacin and lovastatin) Extended-Release Tablets, Abbott Laboratories, Manufacturing Change or Addition | Mevacor (lovastatin) Tablets, Merck & Co., Inc., Labeling Revision | Advicor (lovastatin and niacin) Extended-Release Tablets, Abbott Laboratories, Labeling Revision | Mevacor (lovastatin) Tablets, Merck Sharp & Dohme Corp., Labeling Revision
  
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