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ISOTRETINOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2024-01-29

Drug application

FDA Application #

ANDA218194

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

AUROBINDO PHARMA

Manufacturer

Aurobindo Pharma Limited

First approval

2024-01-29

Source

Authoritative

Drugs@FDA application overview

Machine

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