Orange Book product · Brand (NDA)

PURINETHOL

MERCAPTOPURINE

Brand (NDA)NDA 009053TE ABRX STASON PHARMS

View MERCAPTOPURINE family Open on FDA Orange Book

At a glance

Approved Prior to Jan 1, 1982

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

No patent or exclusivity dates are listed for this product.

Pharmaceutical detail

Active ingredient

MERCAPTOPURINE

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 009053

Product number

002

Marketing status

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.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo