← FDA Drug Approvals (Drugs@FDA)

GLYCOPYRROLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AJENAT PHARMS · Approved 2025-10-27

Drug application

FDA Application #

ANDA219267

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLYCOPYRROLATE

Generic name

GLYCOPYRROLATE

Active ingredients

GLYCOPYRROLATE

Dosage form

SOLUTION

Route

ORAL

Marketing status

Prescription

Sponsor

AJENAT PHARMS

Manufacturer

AJENAT PHARMACEUTICALS LLC

First approval

2025-10-27

Source

Authoritative

Drugs@FDA application overview

Machine

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