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FDA source evidence

ANDA208028

FDA application evidence

ANDA208028

LURASIDONE HYDROCHLORIDE

Application summary

Application number
ANDA208028
Sponsor
INVAGEN PHARMS
Product / brand name
LURASIDONE HYDROCHLORIDE
Active ingredients
LURASIDONE HYDROCHLORIDE
Submission type
SUPPL
Submission status
AP
Submission date
20260515
Review priority
STANDARD
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
TE code
AB
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