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SPIRONOLACTONE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM INDUSTRIES · Approved 1986-07-23

Drug application

FDA Application #

ANDA089424

Application type

Abbreviated New Drug Application (Generic)

Brand name

SPIRONOLACTONE

Generic name

SPIRONOLACTONE

Active ingredients

SPIRONOLACTONE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

SUN PHARM INDUSTRIES

Manufacturer

Sun Pharmaceutical Industries, Inc.

First approval

1986-07-23

Source

Authoritative

Drugs@FDA application overview

Machine

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