Details for New Drug Application (NDA): 213827

NDA 213827 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 213827

Tradename:	METOLAZONE
Applicant:	Innogenix
Ingredient:	metolazone
Patents:	0

Pharmacology for NDA: 213827

Physiological Effect

Increased Diuresis

Medical Subject Heading (MeSH) Categories for 213827

Antihypertensive Agents

Diuretics

Sodium Chloride Symporter Inhibitors

Suppliers and Packaging for NDA: 213827

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOLAZONE	metolazone	TABLET;ORAL	213827	ANDA	Major Pharmaceuticals	0904-7328	0904-7328-61	100 BLISTER PACK in 1 CARTON (0904-7328-61) / 1 TABLET in 1 BLISTER PACK
METOLAZONE	metolazone	TABLET;ORAL	213827	ANDA	Major Pharmaceuticals	0904-7329	0904-7329-61	100 BLISTER PACK in 1 CARTON (0904-7329-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Mar 30, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 30, 2021	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 30, 2021	TE:	AB	RLD:	No

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