Details for New Drug Application (NDA): 215616

NDA 215616 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 215616

Tradename:	METOLAZONE
Applicant:	Renata
Ingredient:	metolazone
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 215616

Physiological Effect

Increased Diuresis

Medical Subject Heading (MeSH) Categories for 215616

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 215616

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOLAZONE	metolazone	TABLET;ORAL	215616	ANDA	Ingenus Pharmaceuticals LLC	50742-349	50742-349-01	100 TABLET in 1 BOTTLE (50742-349-01)
METOLAZONE	metolazone	TABLET;ORAL	215616	ANDA	Ingenus Pharmaceuticals LLC	50742-350	50742-350-01	100 TABLET in 1 BOTTLE (50742-350-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 24, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 24, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 24, 2022	TE:	AB	RLD:	No

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