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FDA NDA · NDA201525

DOCETAXEL

Sponsor: SANDOZ

APPLICATION
NDA201525
TYPE
NDA
ORIGINAL APPROVAL
2011-06-29
LATEST ACTION
2023-09-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DOCETAXELPrescription
DOCETAXEL 160MG/16ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
DOCETAXELPrescription
DOCETAXEL 80MG/8ML (10MG/ML) · INJECTABLE · INJECTION

Approval history

2023-09-21Labeling · Supplement 24 · standard — Letter ↗AP
2021-01-13Labeling · Supplement 22 · standard — Label ↗AP
2020-08-11Labeling · Supplement 20 · standard — Letter ↗AP
2020-01-06Labeling · Supplement 19 · standard — Label ↗AP
2019-03-27Labeling · Supplement 17 · standard — Label ↗AP
2019-03-27Labeling · Supplement 16 · standard — Label ↗AP
2016-10-21Labeling · Supplement 12 · standard — Letter ↗AP
2016-07-25Manufacturing (CMC) · Supplement 11 · standardAP
2014-11-04Labeling · Supplement 8 · standard — Label ↗AP
2014-11-04Labeling · Supplement 9 · standard — Letter ↗AP
2014-08-18Manufacturing (CMC) · Supplement 7 · standardAP
2014-04-23Labeling · Supplement 3 · standard — Letter ↗AP
2012-03-15Labeling · Supplement 2 · unknown — Letter ↗AP
2011-06-29Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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