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Details for New Drug Application (NDA): 076732

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NDA 076732 describes METOLAZONE, which is a drug marketed by Teva, Sandoz, Roxane, Watson Labs, and Mylan, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the METOLAZONE profile page.

The generic ingredient in METOLAZONE 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: 076732

Tradename:
METOLAZONE
Applicant:
Sandoz
Ingredient:
metolazone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076732

Physiological EffectIncreased Diuresis

Suppliers and Packaging for NDA: 076732

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOLAZONE
metolazone
TABLET;ORAL 076732 ANDA Eon Labs, Inc. 0185-5050 0185-5050-01 100 TABLET in 1 BOTTLE (0185-5050-01)
METOLAZONE
metolazone
TABLET;ORAL 076732 ANDA Eon Labs, Inc. 0185-5050 0185-5050-10 1000 TABLET in 1 BOTTLE (0185-5050-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 19, 2003TE:ABRLD:No


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