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Details for New Drug Application (NDA): 209478

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NDA 209478 describes CAROSPIR, which is a drug marketed by Cmp Dev Llc and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the CAROSPIR profile page.

The generic ingredient in CAROSPIR is spironolactone. There are sixteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the spironolactone profile page.

Summary for 209478

Tradename:	CAROSPIR
Applicant:	Cmp Dev Llc
Ingredient:	spironolactone
Patents:	4
Formulation / Manufacturing:	see details

Pharmacology for NDA: 209478

Mechanism of Action

Aldosterone Antagonists

Medical Subject Heading (MeSH) Categories for 209478

Diuretics

Mineralocorticoid Receptor Antagonists

Suppliers and Packaging for NDA: 209478

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CAROSPIR	spironolactone	SUSPENSION;ORAL	209478	NDA	ATLANTIC BIOLOGICALS CORP.	17856-0120	17856-0120-1	72 CUP in 1 BOX (17856-0120-1) > 2.5 mL in 1 CUP
CAROSPIR	spironolactone	SUSPENSION;ORAL	209478	NDA	CMP Pharma, Inc.	46287-020	46287-020-01	473 mL in 1 BOTTLE (46287-020-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	25MG/5ML
Approval Date:	Aug 4, 2017	TE:		RLD:	Yes
Patent:		Patent Expiration:	Oct 28, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Oct 28, 2036	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:		Patent Expiration:	Oct 28, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

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