Orange Book product · Brand (NDA)

RASUVO

METHOTREXATE

Brand (NDA)NDA 205776RX MEDEXUS

Jul 10, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 10, 2014
12 yr 1 mo ago
Today
Patent 8664231 expires
Listed method-of-use patent (U-1442) expiration.
Jun 01, 2029
in 3 yr

Active ingredient

METHOTREXATE

Strength

7.5MG/0.15ML (7.5MG/0.15ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

Not listed

Application

NDA 205776

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

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

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8664231	Jun 01, 2029	in 3 yr	U-1442