← FDA Drug Approvals (Drugs@FDA)

ISOTRETINOIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: UPSHER SMITH LABS · Approved 2021-04-12

Drug application

FDA Application #

ANDA213571

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

UPSHER SMITH LABS

Manufacturer

Upsher-Smith Laboratories, LLC

First approval

2021-04-12

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown