← FDA Drug Approvals (Drugs@FDA)

AMLODIPINE BESYLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ORBION PHARMS · Approved 2009-07-02

Drug application

FDA Application #

ANDA078453

Application type

Abbreviated New Drug Application (Generic)

Brand name

AMLODIPINE BESYLATE

Generic name

Amlodipine Besylate

Active ingredients

AMLODIPINE BESYLATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ORBION PHARMS

First approval

2009-07-02

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown