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FDA ANDA · ANDA211642

THIOTHIXENE

Sponsor: NOVITIUM PHARMA

APPLICATION
ANDA211642
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-05
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

THIOTHIXENEPrescription
THIOTHIXENE 10MG · CAPSULE · ORAL
THIOTHIXENEPrescription
THIOTHIXENE 2MG · CAPSULE · ORAL
THIOTHIXENEPrescription
THIOTHIXENE 5MG · CAPSULE · ORAL
THIOTHIXENEPrescription
THIOTHIXENE 1MG · CAPSULE · ORAL

Approval history

2025-01-22Labeling · Supplement 21 · standardAP
2019-04-05UNKNOWN · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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