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Details for New Drug Application (NDA): 016042

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NDA 016042 describes DYAZIDE, which is a drug marketed by Glaxosmithkline Llc and is included in one NDA. It is available from one supplier. Additional details are available on the DYAZIDE profile page.

The generic ingredient in DYAZIDE is hydrochlorothiazide; triamterene. There are thirty-one drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; triamterene profile page.

Summary for NDA: 016042

Tradename:
DYAZIDE
Applicant:
Glaxosmithkline Llc
Ingredient:
hydrochlorothiazide; triamterene
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 016042

Suppliers and Packaging for NDA: 016042

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DYAZIDE
hydrochlorothiazide; triamterene
CAPSULE;ORAL 016042 NDA GlaxoSmithKline LLC 0007-3650 0007-3650-22 100 CAPSULE in 1 BOTTLE (0007-3650-22)
DYAZIDE
hydrochlorothiazide; triamterene
CAPSULE;ORAL 016042 NDA GlaxoSmithKline LLC 0007-3650 0007-3650-30 1000 CAPSULE in 1 BOTTLE (0007-3650-30)

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG;50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG;37.5MG
Approval Date:Mar 3, 1994TE:ABRLD:Yes


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