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FDA ANDA · ANDA208137

DOCETAXEL

Sponsor: MYLAN LABS LTD

APPLICATION
ANDA208137
TYPE
ANDA
ORIGINAL APPROVAL
2019-04-01
LATEST ACTION
2024-05-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DOCETAXELPrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION

Approval history

2024-05-08Labeling · Supplement 6 · standardAP
2019-04-01UNKNOWN · 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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