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Last Updated: October 12, 2024

Details for New Drug Application (NDA): 076732


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NDA 076732 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Innogenix, Leading, 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 076732
Tradename:METOLAZONE
Applicant:Sandoz
Ingredient:metolazone
Patents:0
Pharmacology for NDA: 076732
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for 076732
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 Sandoz Inc 0185-5050 0185-5050-01 100 TABLET in 1 BOTTLE (0185-5050-01)
METOLAZONE metolazone TABLET;ORAL 076732 ANDA Sandoz Inc 0185-5050 0185-5050-10 1000 TABLET in 1 BOTTLE (0185-5050-10)

Profile for product number 001

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

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