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Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076698

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NDA 076698 describes METOLAZONE, which is a drug marketed by Mylan, Roxane, Sandoz, Teva, and Watson Labs, 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 076698
Tradename:METOLAZONE
Applicant:Mylan
Ingredient:metolazone
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076698
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 076698
Suppliers and Packaging for NDA: 076698
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOLAZONE metolazone TABLET;ORAL 076698 ANDA Mylan Pharmaceuticals Inc. 0378-6172 N 0378-6172-01
METOLAZONE metolazone TABLET;ORAL 076698 ANDA Mylan Pharmaceuticals Inc. 0378-6173 N 0378-6173-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Dec 23, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 19, 2004TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Oct 19, 2004TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
UBS
Cantor Fitzgerald
Boehringer Ingelheim
Citi
Covington
Chubb
Healthtrust
QuintilesIMS

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