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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 076466


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NDA 076466 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Innogenix, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, and Watson Labs, and is included in twelve NDAs. It is available from seventeen suppliers. Additional details are available on the METOLAZONE profile page.

The generic ingredient in METOLAZONE is metolazone. There are ten drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the metolazone profile page.
Summary for 076466
Tradename:METOLAZONE
Applicant:Sandoz
Ingredient:metolazone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076466
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 076466
Suppliers and Packaging for NDA: 076466
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOLAZONE metolazone TABLET;ORAL 076466 ANDA Sandoz Inc 0185-0055 0185-0055-01 100 TABLET in 1 BOTTLE (0185-0055-01)
METOLAZONE metolazone TABLET;ORAL 076466 ANDA Sandoz Inc 0185-0055 0185-0055-10 1000 TABLET in 1 BOTTLE (0185-0055-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 19, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 19, 2003TE:ABRLD:No

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