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PALIPERIDONE PALMITATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TOLMAR · Approved 2023-06-30

Drug application

FDA Application #
ANDA211995
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
INTRAMUSCULAR
Marketing status
None (Tentative Approval)
Sponsor
TOLMAR
First approval
2023-06-30

Source

Authoritative
Drugs@FDA application overview
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