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FDA Approval Activities for this Drug…
Lipitor (atorvastatin calcium) tablets, Parke-Davis Pharmaceutical Research, agent for Warner-Lambert Export, Limited NDA 20-702 /S-003/S-005 7/10/98 7/10/98 11/12/98 Lipitor Indications: S-003 provides for the use of Lipitor as an adjunctive therapy to diet for the treatment of patients with elevated serium triglyceride levels (Frederickson Type IV). S-005 provides for the use of Lipitor by patients with primary dysbetalipoproteinemia (Frederickson Type III) who do not respond adequately to diet. Lipitor (atorvastatin calcium) tablets, Parke-Davis Pharmaceutical Research, agent for Warner-Lambert Export, Limited NDA 20-702 /S-004 2/2/98 10/23/98 Lipitor (atorvastatin calcium) tablets, Parke-Davis Pharmaceutical Research, agent for Warner-Lambert Export, Limited NDA 20-702 /S-14 8/28/98 12/14/98 Lipitor (atorvastatin calcium) tablets, Parke-Davis, agent for Warner-Lambert Export, Limited NDA 20-702 /S-18 12/2/99 12/29/99 4/23/03 Lipitor (atorvastatin calcium) Tablets, Pfizer Ireland NDA 20-702 /S-25 6/15/01 11/6/01 11/6/01 4/10/02 Lipitor (atorvastatin calcium) Tablets, Pfizer, NDA 20-702/S-33 10/18/02 10/28/02 10/18/02 Lipitor (atorvastatin calcium) Tablets, Pfizer Ireland NDA 20-702 /S29 & S34 4/22/02 5/2/02 4/24/02 Lipitor (atorvastatin calcium) Tablets, Pfizer NDA 20-702/S37 9/29/03 10/9/03 10/10/03 Lipitor (atorvastatin calcium) Tablets, Pfizer NDA 20-702/S36 Caduet (amlodipine besylate/atorvastatin calcium) Tablets, Pfizer Inc. Lipitor (Atorvastatin calcium) tablets, Pfizer Lipitor (Atorvastatin calcium) tablets, Pfizer Inc., New or Modified Indication | Caduet (amlodipine besylate/atorvastatin calcium) Tablets, Pfizer Inc., Supplement | Lipitor (Atorvastatin calcium) tablets, Pfizer Inc., Labeling Revision | Caduet (amlodipine besylate and atorvastatin calcium) Tablets, Pfizer, Labeling Revision | Lipitor (atorvastatin calcium) Tablets, Pfizer Inc., Labeling Revision | Lipitor (atorvastatin calcium) Tablets, Pfizer Inc., Labeling Revision | Caduet Tablet, Pfizer, Labeling Revision | Lipitor (atorvastatin calcium) Tablets, Pfizer, New or Modified Indication
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