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DELSYM

NDA · New Drug Application · Sponsor: RB HLTH · Approved 1982-10-08

Drug application

FDA Application #

NDA018658

Application type

New Drug Application

Brand name

DELSYM

Generic name

DEXTROMETHORPHAN

Active ingredients

DEXTROMETHORPHAN POLISTIREX

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

RB HLTH

Manufacturer

RB Health (US) LLC

First approval

1982-10-08

Source

Authoritative

Drugs@FDA application overview

Machine

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