Details for New Drug Application (NDA): 216216

NDA 216216 describes METOLAZONE, which is a drug marketed by Alembic, Ani Pharms, Bayshore Pharms Llc, Chemistry Hlth, Innogenix, Micro Labs, Mylan, Ne Rx Pharma, Renata, Roxane, Rubicon, Sandoz, and Watson Labs, and is included in fourteen 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 216216

Tradename:	METOLAZONE
Applicant:	Ne Rx Pharma
Ingredient:	metolazone
Patents:	0

Pharmacology for NDA: 216216

Physiological Effect

Increased Diuresis

Medical Subject Heading (MeSH) Categories for 216216

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 216216

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOLAZONE	metolazone	TABLET;ORAL	216216	ANDA	Marlex Pharmaceuticals, Inc.	10135-765	10135-765-01	100 TABLET in 1 BOTTLE (10135-765-01)
METOLAZONE	metolazone	TABLET;ORAL	216216	ANDA	Marlex Pharmaceuticals, Inc.	10135-765	10135-765-10	1000 TABLET in 1 BOTTLE (10135-765-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 25, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 25, 2022	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 25, 2022	TE:	AB	RLD:	No

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