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Details for New Drug Application (NDA): 017386

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NDA 017386 describes ZAROXOLYN, which is a drug marketed by Ucb Inc and is included in one NDA. It is available from three suppliers. Additional details are available on the ZAROXOLYN profile page.

The generic ingredient in ZAROXOLYN is metolazone. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the metolazone profile page.

Summary for NDA: 017386

Tradename:
ZAROXOLYN
Applicant:
Ucb Inc
Ingredient:
metolazone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 017386

Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 017386

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZAROXOLYN
metolazone
TABLET;ORAL 017386 NDA AUTHORIZED GENERIC Aphena Pharma Solutions - Tennessee, LLC 43353-999 43353-999-09 9000 TABLET in 1 BOTTLE, PLASTIC (43353-999-09)
ZAROXOLYN
metolazone
TABLET;ORAL 017386 NDA AUTHORIZED GENERIC Upstate Pharma, LLC 65580-643 65580-643-71 100 TABLET in 1 BOTTLE, PLASTIC (65580-643-71)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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