| Betterchem |

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| FDA approval activities
for this prescription 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., Tentatively Approved 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., Tentatively Approved 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., Tentatively Approved 7/18/01 Eon Labs Manufacturing, ANDA 75-636 7/18/01 Lovastatin Tablets USP, 10mg, 20mg, & 40mg., Tentatively Approved 4/28/00 Eon Labs Manufacturing, ANDA 75-636 4/28/00 4/28/00 Lovastatin Tablets USP, 10mg, 20mg, & 40mg, Tentatively Approved 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, Tentatively Approved 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, Tentatively Approved 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 |
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