Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 018422

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LOPID (GEMFIBROZIL)
600MG
Marketing Status: Prescription

Active Ingredient: GEMFIBROZIL
Proprietary Name: LOPID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 600MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N018422
Product Number: 003
Approval Date: Nov 20, 1986
Applicant Holder Full Name: PFIZER PHARMACEUTICALS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

LOPID (GEMFIBROZIL)
200MG
Marketing Status: Discontinued

Active Ingredient: GEMFIBROZIL
Proprietary Name: LOPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 200MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018422
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information

LOPID (GEMFIBROZIL)
300MG
Marketing Status: Discontinued

Active Ingredient: GEMFIBROZIL
Proprietary Name: LOPID
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N018422
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: PFIZER PHARMACEUTICALS LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information