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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021807
Company: MAYNE PHARMA COMMRCL

Medication Guide

Products on NDA 021807

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SOLTAMOX	TAMOXIFEN CITRATE	EQ 20MG BASE/10ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/2005	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021807ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021807s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2019	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021807Orig1s006ltr.pdf
09/25/2018	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021807Orig1s005ltr.pdf
04/22/2015	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
01/28/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 021807

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/08/2019	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf
04/08/2019	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf
09/25/2018	SUPPL-5	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021807s005lbl.pdf
10/29/2005	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021807lbl.pdf

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