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ERTAPENEM SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACS DOBFAR SPA · Approved 2018-04-16

Drug application

FDA Application #

ANDA208790

Application type

Abbreviated New Drug Application (Generic)

Brand name

ERTAPENEM SODIUM

Generic name

ERTAPENEM SODIUM

Active ingredients

ERTAPENEM SODIUM

Dosage form

INJECTABLE

Route

INTRAMUSCULAR, INTRAVENOUS

Marketing status

Prescription

Sponsor

ACS DOBFAR SPA

Manufacturer

Fresenius Kabi USA, LLC

First approval

2018-04-16

Source

Authoritative

Drugs@FDA application overview

Machine

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