← FDA Drug Approvals (Drugs@FDA)

GLYCOPYRROLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CAPLIN · Approved 2019-03-20

Drug application

FDA Application #

ANDA211705

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLYCOPYRROLATE

Generic name

GLYCOPYRROLATE

Active ingredients

GLYCOPYRROLATE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

CAPLIN

Manufacturer

Somerset Therapeutics, LLC

First approval

2019-03-20

Source

Authoritative

Drugs@FDA application overview

Machine

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