Details for New Drug Application (NDA): 213251

NDA 213251 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 213251

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

Pharmacology for NDA: 213251

Physiological Effect

Increased Diuresis

Medical Subject Heading (MeSH) Categories for 213251

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 213251

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Major Pharmaceuticals	0904-7138	0904-7138-61	100 BLISTER PACK in 1 CARTON (0904-7138-61) / 1 TABLET in 1 BLISTER PACK
METOLAZONE	metolazone	TABLET;ORAL	213251	ANDA	Major Pharmaceuticals	0904-7139	0904-7139-61	100 BLISTER PACK in 1 CARTON (0904-7139-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Dec 2, 2020	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 2, 2020	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Dec 2, 2020	TE:	AB	RLD:	No

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