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FDA NDA · NDA021807

SOLTAMOX

tamoxifen citrate

Sponsor: MAYNE PHARMA COMMRCL

APPLICATION
NDA021807
TYPE
NDA
ORIGINAL APPROVAL
2005-10-29
LATEST ACTION
2019-04-08
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

SOLTAMOX · ReferencePrescription
TAMOXIFEN CITRATE EQ 20MG BASE/10ML · SOLUTION · ORAL

Approval history

2019-04-08Labeling · Supplement 6 · standard — Label ↗AP
2018-09-25Efficacy · Supplement 5 · standard — Label ↗AP
2015-04-22Manufacturing (CMC) · Supplement 3 · standardAP
2013-01-28Manufacturing (CMC) · Supplement 2 · standardAP
2005-10-29Type 3 - New Dosage Form · Original · standard — Medication Guide ↗AP
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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