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PALIPERIDONE PALMITATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN PHARMACEUTICALS INC A VIATRIS CO · Approved 2024-12-03

Drug application

FDA Application #

ANDA215682

Application type

Abbreviated New Drug Application (Generic)

Brand name

PALIPERIDONE PALMITATE

Generic name

Paliperidone Palmitate

Active ingredients

PALIPERIDONE PALMITATE

Dosage form

INJECTION

Route

SUSPENSION

Marketing status

None (Tentative Approval)

Sponsor

MYLAN PHARMACEUTICALS INC A VIATRIS CO

First approval

2024-12-03

Source

Authoritative

Drugs@FDA application overview

Machine

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