← FDA DRUG APPROVALS

FDA ANDA · ANDA070929

TAMOXIFEN CITRATE

Sponsor: ACTAVIS LABS FL INC

APPLICATION
ANDA070929
TYPE
ANDA
ORIGINAL APPROVAL
2003-02-20
LATEST ACTION
2007-01-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TAMOXIFEN CITRATEPrescription
TAMOXIFEN CITRATE EQ 10MG BASE · TABLET · ORAL
TAMOXIFEN CITRATEPrescription
TAMOXIFEN CITRATE EQ 20MG BASE · TABLET · ORAL

Approval history

2007-01-25Labeling · Supplement 5AP
2003-02-20OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →