Orange Book product · Brand (NDA)

SOLTAMOX

TAMOXIFEN CITRATE

Brand (NDA)NDA 021807RX MAYNE PHARMA COMMRCL

View TAMOXIFEN CITRATE family Open on FDA Orange Book

At a glance

Oct 29, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 29, 2005
20 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

TAMOXIFEN CITRATE

Strength

EQ 20MG BASE/10ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 021807

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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