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Last Updated: November 2, 2024

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 three suppliers. There are eight 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. Forty-three 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:8
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 AUTHORIZED GENERIC Padagis US LLC 0574-1133 0574-1133-04 118 mL in 1 BOTTLE (0574-1133-04)
CAROSPIR spironolactone SUSPENSION;ORAL 209478 NDA AUTHORIZED GENERIC Padagis US LLC 0574-1133 0574-1133-10 10 CUP, UNIT-DOSE in 1 CARTON (0574-1133-10) / 5 mL in 1 CUP, UNIT-DOSE (0574-1133-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/5ML
Approval Date:Aug 4, 2017TE:ABRLD:Yes
Patent:⤷  Sign UpPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Oct 28, 2036Product Flag?YSubstance Flag?Delist Request?

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