Product Details for NDA 016042
DYAZIDE (HYDROCHLOROTHIAZIDE; TRIAMTERENE)
25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; TRIAMTERENE
Proprietary Name: DYAZIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016042
Product Number: 003
Approval Date: Mar 3, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
DYAZIDE (HYDROCHLOROTHIAZIDE; TRIAMTERENE)
Proprietary Name: DYAZIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N016042
Product Number: 003
Approval Date: Mar 3, 1994
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: HYDROCHLOROTHIAZIDE; TRIAMTERENE
Proprietary Name: DYAZIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016042
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: DYAZIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 25MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: N016042
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: GLAXOSMITHKLINE LLC
Marketing Status: Discontinued
Patent and Exclusivity Information