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FDA ANDA · ANDA208302

IMATINIB MESYLATE

Sponsor: SHILPA

APPLICATION
ANDA208302
TYPE
ANDA
ORIGINAL APPROVAL
2019-01-17
LATEST ACTION
2023-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 400MG BASE · TABLET · ORAL
IMATINIB MESYLATEPrescription
IMATINIB MESYLATE EQ 100MG BASE · TABLET · ORAL

Approval history

2023-06-09Labeling · Supplement 2 · standardAP
2023-06-09Labeling · Supplement 7 · standardAP
2023-06-09Labeling · Supplement 6 · standardAP
2019-01-17UNKNOWN · 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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