Orange Book product · Brand (NDA)

DECA-DURABOLIN

NANDROLONE DECANOATE

Brand (NDA)NDA 013132DISCN WOODWARD SPECL

View NANDROLONE DECANOATE family Open on FDA Orange Book

At a glance

Jun 12, 1986

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Jun 12, 1986
40 yr 7 mo ago
Today

Pharmaceutical detail

Active ingredient

NANDROLONE DECANOATE

Strength

200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

INJECTABLE

Route

INJECTION

TE code

Not listed

Application

NDA 013132

Product number

003

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.

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

Book a Demo