Product Details for NDA 018538
LOZOL (INDAPAMIDE)
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: INDAPAMIDE
Proprietary Name: LOZOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018538
Product Number: 002
Approval Date: Apr 29, 1993
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
LOZOL (INDAPAMIDE)
Proprietary Name: LOZOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018538
Product Number: 002
Approval Date: Apr 29, 1993
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: INDAPAMIDE
Proprietary Name: LOZOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018538
Product Number: 001
Approval Date: Jul 6, 1983
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: LOZOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N018538
Product Number: 001
Approval Date: Jul 6, 1983
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information