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GYNAZOLE-1

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS ISRAEL · Approved 2012-05-18

Drug application

FDA Application #

ANDA200923

Application type

Abbreviated New Drug Application (Generic)

Brand name

GYNAZOLE-1

Generic name

BUTOCONAZOLE NITRATE

Active ingredients

BUTOCONAZOLE NITRATE

Dosage form

CREAM

Route

VAGINAL

Marketing status

Prescription

Sponsor

PADAGIS ISRAEL

Manufacturer

Padagis Israel Pharmaceuticals Ltd

First approval

2012-05-18

Source

Authoritative

Drugs@FDA application overview

Machine

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