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AMITRIPTYLINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA USA · Approved 1978-04-10

Drug application

FDA Application #

ANDA086009

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMITRIPTYLINE HYDROCHLORIDE

Generic name

AMITRIPTYLINE HYDROCHLORIDE

Active ingredients

AMITRIPTYLINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AUROBINDO PHARMA USA

Manufacturer

Aurobindo Pharma Limited

First approval

1978-04-10

Source

Authoritative

Drugs@FDA application overview

Machine

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