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ISOTRETINOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ZYDUS PHARMS · Approved 2025-05-22

Drug application

FDA Application #

ANDA216633

Application type

Abbreviated New Drug Application (Generic)

Brand name

ISOTRETINOIN

Generic name

ISOTRETINOIN

Active ingredients

ISOTRETINOIN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

ZYDUS PHARMS

Manufacturer

Zydus Pharmaceuticals USA Inc.

First approval

2025-05-22

Source

Authoritative

Drugs@FDA application overview

Machine

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