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FDA ANDA · ANDA209267

ERLOTINIB

Sponsor: HETERO LABS LTD V

APPLICATION
ANDA209267
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-24
LATEST ACTION
2024-05-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ERLOTINIB HYDROCHLORIDEPrescription
ERLOTINIB HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
ERLOTINIB HYDROCHLORIDEPrescription
ERLOTINIB HYDROCHLORIDE EQ 150MG BASE · TABLET · ORAL
ERLOTINIB HYDROCHLORIDEPrescription
ERLOTINIB HYDROCHLORIDE EQ 25MG BASE · TABLET · ORAL

Approval history

2024-05-24UNKNOWN · Original · standardAP
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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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