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EPOPROSTENOL SODIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GLAND · Approved 2025-12-29

Drug application

FDA Application #
ANDA219237
Application type
Abbreviated New Drug Application (Generic)
Brand name
EPOPROSTENOL SODIUM
Generic name
EPOPROSTENOL
Active ingredients
EPOPROSTENOL SODIUM
Dosage form
INJECTABLE
Route
INJECTION
Marketing status
Prescription
Sponsor
GLAND
Manufacturer
Gland Pharma Limited
First approval
2025-12-29

Source

Authoritative
Drugs@FDA application overview
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