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FDA source evidence

ANDA208047

FDA application evidence

ANDA208047

LURASIDONE HYDROCHLORIDE

Application summary

Application number
ANDA208047
Sponsor
DR REDDYS
Product / brand name
LURASIDONE HYDROCHLORIDE
Active ingredients
LURASIDONE HYDROCHLORIDE
Submission type
SUPPL
Submission status
AP
Submission date
20260601
Review priority
STANDARD
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
TE code
AB
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