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SPIRONOLACTONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2023-09-05

Drug application

FDA Application #

ANDA215572

Application type

Abbreviated New Drug Application (Generic)

Brand name

SPIRONOLACTONE

Generic name

SPIRONOLACTONE

Active ingredients

SPIRONOLACTONE

Dosage form

SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL

Manufacturer

Amneal Pharmaceuticals NY LLC

First approval

2023-09-05

Source

Authoritative

Drugs@FDA application overview

Machine

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