← FDA Drug Approvals (Drugs@FDA)

RIFABUTIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2021-12-17

Drug application

FDA Application #

ANDA215041

Application type

Abbreviated New Drug Application (Generic)

Brand name

RIFABUTIN

Generic name

RIFABUTIN

Active ingredients

RIFABUTIN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Prescription

Sponsor

NOVITIUM PHARMA

Manufacturer

ANI Pharmaceuticals, Inc.

First approval

2021-12-17

Source

Authoritative

Drugs@FDA application overview

Machine

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