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PALIPERIDONE PALMITATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN PHARMS INC · Approved 2024-05-20

Drug application

FDA Application #
ANDA216228
Application type
Abbreviated New Drug Application (Generic)
Brand name
PALIPERIDONE PALMITATE
Generic name
Paliperidone Palmitate
Active ingredients
PALIPERIDONE PALMITATE
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
INJECTABLE
Marketing status
None (Tentative Approval)
Sponsor
MYLAN PHARMS INC
First approval
2024-05-20

Source

Authoritative
Drugs@FDA application overview
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