Product Details for NDA 011721
NEPTAZANE (METHAZOLAMIDE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHAZOLAMIDE
Proprietary Name: NEPTAZANE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011721
Product Number: 002
Approval Date: Nov 25, 1991
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information
NEPTAZANE (METHAZOLAMIDE)
Proprietary Name: NEPTAZANE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011721
Product Number: 002
Approval Date: Nov 25, 1991
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information
50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: METHAZOLAMIDE
Proprietary Name: NEPTAZANE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011721
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: NEPTAZANE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N011721
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO
Marketing Status: Discontinued
Patent and Exclusivity Information