Orange Book product · Brand (NDA)

METHOTREXATE

Brand (NDA)NDA 214121DISCN ACCORD HLTHCARE

View METHOTREXATE family Open on FDA Orange Book

At a glance

Aug 24, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Aug 24, 2020
5 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

METHOTREXATE

Strength

5GM/50ML (100MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 214121

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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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