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PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SEPTODONT INC · Approved 2011-08-30

Drug application

FDA Application #

ANDA078959

Application type

Abbreviated New Drug Application (Generic)

Brand name

PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE

Generic name

PRILOCAINE HCL AND EPINEPHRINE

Active ingredients

EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

SEPTODONT INC

Manufacturer

Dentsply Pharmaceutical Inc.

First approval

2011-08-30

Source

Authoritative

Drugs@FDA application overview

Machine

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