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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 Visit Betterchem's Drug Index for FDA's latest approval information.   Find other drugs… A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | USActives.com | Pharma Job Search | Pharma Company News © 2011 FindingHealthOnline™