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LEUPROLIDE ACETATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2025-11-13

Drug application

FDA Application #

ANDA215826

Application type

Abbreviated New Drug Application (Generic)

Brand name

LEUPROLIDE ACETATE

Generic name

LEUPROLIDE ACETATE

Active ingredients

LEUPROLIDE ACETATE

Dosage form

SOLUTION

Route

SUBCUTANEOUS

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2025-11-13

Source

Authoritative

Drugs@FDA application overview

Machine

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