← FDA Drug Approvals (Drugs@FDA)

GLATIRAMER ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SYNTHON PHARMS INC · Approved 2024-09-25

Drug application

FDA Application #

ANDA203857

Application type

Abbreviated New Drug Application (Generic)

Brand name

GLATIRAMER ACETATE

Generic name

GLATIRAMER ACETATE

Active ingredients

GLATIRAMER ACETATE

Dosage form

INJECTABLE

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

SYNTHON PHARMS INC

Manufacturer

Sun Pharmaceutical Industries, Inc.

First approval

2024-09-25

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown