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FDA ANDA · ANDA207105

ARIPIPRAZOLE

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA207105
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-21
LATEST ACTION
2023-07-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 15MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 5MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 20MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 10MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 2MG · TABLET · ORAL
ARIPIPRAZOLEPrescription
ARIPIPRAZOLE 30MG · TABLET · ORAL

Approval history

2023-07-17Labeling · Supplement 3 · standardAP
2023-07-17Labeling · Supplement 8 · standardAP
2023-07-17Labeling · Supplement 2 · standardAP
2019-02-21UNKNOWN · Original · standardAP
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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