Product Details for NDA 012283
HYGROTON (CHLORTHALIDONE)
25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: CHLORTHALIDONE
Proprietary Name: HYGROTON
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Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012283
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
HYGROTON (CHLORTHALIDONE)
Proprietary Name: HYGROTON
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Strength: 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012283
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
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50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: CHLORTHALIDONE
Proprietary Name: HYGROTON
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Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012283
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: HYGROTON
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Strength: 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N012283
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANOFI AVENTIS US LLC
Marketing Status: Discontinued
Patent and Exclusivity Information