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FDA NDA · NDA208216

AZACITIDINE

Sponsor: ACTAVIS LLC

APPLICATION
NDA208216
TYPE
NDA
ORIGINAL APPROVAL
2016-04-29
LATEST ACTION
2024-12-19
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

AZACITIDINEPrescription
AZACITIDINE 100MG/VIAL · POWDER · INTRAVENOUS, SUBCUTANEOUS

Approval history

2024-12-19Labeling · Supplement 7 · standard — Letter ↗AP
2023-06-08Labeling · Supplement 6 · standard — Letter ↗AP
2020-07-13Labeling · Supplement 5 · standard — Label ↗AP
2018-10-22Labeling · Supplement 2 · standard — Letter ↗AP
2018-01-10Labeling · Supplement 1 · standard — Label ↗AP
2016-04-29Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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