Product Details for NDA 017386
ZAROXOLYN (METOLAZONE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
Active Ingredient: METOLAZONE
Proprietary Name: ZAROXOLYN
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Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017386
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZAROXOLYN (METOLAZONE)
Proprietary Name: ZAROXOLYN
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Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017386
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METOLAZONE
Proprietary Name: ZAROXOLYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N017386
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
ZAROXOLYN (METOLAZONE)
Proprietary Name: ZAROXOLYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 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: N017386
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METOLAZONE
Proprietary Name: ZAROXOLYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **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: N017386
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ZAROXOLYN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **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: N017386
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: I3 PHARMACEUTICALS LLC
Marketing Status: Discontinued
Patent and Exclusivity Information