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FDA ANDA · ANDA213984

CARIPRAZINE HYDROCHLORIDE

Sponsor: ZYDUS

APPLICATION
ANDA213984
TYPE
ANDA
ORIGINAL APPROVAL
2022-09-09
LATEST ACTION
2022-09-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CARIPRAZINE HYDROCHLORIDEDiscontinued
CARIPRAZINE HYDROCHLORIDE EQ 6MG BASE · CAPSULE · ORAL
CARIPRAZINE HYDROCHLORIDEDiscontinued
CARIPRAZINE HYDROCHLORIDE EQ 3MG BASE · CAPSULE · ORAL
CARIPRAZINE HYDROCHLORIDEDiscontinued
CARIPRAZINE HYDROCHLORIDE EQ 4.5MG BASE · CAPSULE · ORAL
CARIPRAZINE HYDROCHLORIDEDiscontinued
CARIPRAZINE HYDROCHLORIDE EQ 1.5MG BASE · CAPSULE · ORAL

Approval history

2022-09-09UNKNOWN · 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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