← FDA Drug Approvals (Drugs@FDA)

GLYCOPYRROLATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2018-11-30

Drug application

FDA Application #

ANDA203657

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLYCOPYRROLATE

Generic name

GLYCOPYRROLATE

Active ingredients

GLYCOPYRROLATE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ALEMBIC

Manufacturer

Alembic Labs LLC

First approval

2018-11-30

Source

Authoritative

Drugs@FDA application overview

Machine

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