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Generated: September 25, 2018

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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 is one patent 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. Forty-six 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:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 209478
Mechanism of ActionAldosterone Antagonists
Medical Subject Heading (MeSH) Categories for 209478
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:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:Aug 4, 2017TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE

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