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OXYBUTYNIN CHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2017-10-23

Drug application

FDA Application #

ANDA209823

Application type

Abbreviated New Drug Application (Generic)

Brand name

OXYBUTYNIN CHLORIDE

Generic name

OXYBUTYNIN CHLORIDE

Active ingredients

OXYBUTYNIN CHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2017-10-23

Source

Authoritative

Drugs@FDA application overview

Machine

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