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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 076698


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NDA 076698 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, and Watson Labs, and is included in thirteen NDAs. It is available from eighteen 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. Eighteen 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
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 0378-6172-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-6172-01)
METOLAZONE metolazone TABLET;ORAL 076698 ANDA Mylan Pharmaceuticals Inc. 0378-6173 0378-6173-01 100 TABLET in 1 BOTTLE, PLASTIC (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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